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종합비타민 (노인)

Multivitamin (Senior)

📑 PubMed 3편 💊 비타민

📚 관련 논문 (17편)

1.
Riboflavin supplements for blood pressure lowering in adults.
The Cochrane database of systematic reviews 2025 PMID:41123035

1. Cochrane Database Syst Rev. 2025 Oct 22;10(10):CD015464. doi: 10.1002/14651858.CD015464.pub2. Riboflavin supplements for blood pressure lowering in adults. Bradbury KE(1), Coffey S(2), Earle N(3), Ni Mhurchu C(1), Jull AB(4). Author information: (1)School of Population Health, University of A

2.
Potential Dietary Supplement and Medication Interactions in a Subset of the Older Adult Population Attending Congregate Sites.
Journal of nutrition in gerontology and geriatrics 2018 PMID:30398092

2. J Nutr Gerontol Geriatr. 2018 Jul-Dec;37(3-4):218-230. doi: 10.1080/21551197.2018.1519481. Epub 2018 Nov 6. Potential Dietary Supplement and Medication Interactions in a Subset of the Older Adult Population Attending Congregate Sites. de Leon TV(1), He M(1), Ullevig SL(1). Author information

3.
Vitamin D supplementation and health-related quality of life: a systematic review of the literature.
Journal of the Academy of Nutrition and Dietetics 2015 PMID:25573654

3. J Acad Nutr Diet. 2015 Mar;115(3):406-418. doi: 10.1016/j.jand.2014.10.023. Epub 2015 Jan 6. Vitamin D supplementation and health-related quality of life: a systematic review of the literature. Hoffmann MR, Senior PA, Mager DR. Vitamin D deficiency and insufficiency are highly prevalent worl

4.
Effects of cocoa extract supplementation on physical performance measures: results from the randomized controlled COcoa Supplement and Multivitamin Outcomes study.
JBMR plus 2026 PMID:42004609

1. JBMR Plus. 2026 Mar 18;10(5):ziag041. doi: 10.1093/jbmrpl/ziag041. eCollection 2026 May. Effects of cocoa extract supplementation on physical performance measures: results from the randomized controlled COcoa Supplement and Multivitamin Outcomes study. Chou SH(1)(2), Cook N(2)(3)(4), Kim E(2)(3)(4), Kotler G(2)(3)(4), Ganz DA(5)(6)(7), Cawthon PM(8)(9), Clar A(2)(3)(4), Shadyab AH(10)(11), Manson JE(2)(3)(4), Sesso HD(2)(3)(4), Crandall CJ(12), LeBoff M(1)(2). Author information: (1)Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Boston, MA 02115, United States. (2)Harvard Medical School, Boston, MA 02115, United States. (3)Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA  02115, United States. (4)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, United States. (5)Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, CA 90095, United States. (6)Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles, CA 90073, United States. (7)RAND, Santa Monica, CA 90401, United States. (8)Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA 94115, United States. (9)California Pacific Medical Center, Research Institute, San Francisco, CA 94143, United States. (10)Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, CA 92093, United States. (11)Division of Geriatrics, Gerontology, and Palliative Care, Department of Medicine, University of California San Diego, La Jolla, CA 92093, United States. (12)Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, CA 90024, United States. Poor physical performance is associated with a higher risk of falls, fractures, and premature death among older adults. We determined whether supplementation with cocoa extract vs placebo or multivitamin/multimineral (MVM) vs placebo for 2 yr benefited physical performance measures. The COcoa Supplement and Multivitamin Outcomes Study was a double-blinded, placebo-controlled randomized trial of supplemental cocoa extract and/or MVM vs placebo for the primary prevention of cardiovascular disease and cancer in 21 442 US adults. This ancillary study was completed in a New England sub-cohort that underwent physical performance measurements, including grip strength, walking speed, standing balance, repeated chair stands, and timed-up and go (TUG) test, at baseline and 2-yr follow-up. In the clinic sub-cohort (n = 603) with a mean (±SD) age of 69.7 ± 5.5 yr and 49.3% women, supplemental cocoa extract, compared to cocoa-extract placebo, did not affect 2-yr changes in our primary pre-specified, co-equal outcomes of grip strength, walking speed, and the Short Physical Performance Battery (composite of walking speed, standing balance, and chair stands) or in secondary outcomes of standing balance, chair stands, or TUG tests. No effect modification by baseline characteristics of age, sex, body mass index, or randomization to MVM supplementation was observed. In parallel analyses, MVM, compared to MVM placebo, also did not affect physical performance measures. Supplementation with cocoa extract did not prevent age-related declines in physical performance measures in older ambulatory US men and women. © The Author(s) 2026. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research. DOI: 10.1093/jbmrpl/ziag041 PMCID: PMC13089503 PMID: 42004609 Conflict of interest statement: E.K., G.K., A.C., N.C., S.H.C., A.H.S.: None declared. D.A.G. reports funding from National Institute of Aging, Department of Veterans Affairs. C.J.C. reports grants from the National Institutes of Health during the conduct of this study. H.D.S. reports receiving investigator-initiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging, and Pfizer Consumer Healthcare (now Haleon) for donation of COSMOS study pills and packaging during the conduct of the study. H.D.S. additionally reports receiving investigator-initiated grants from Pure Encapsulations and Pfizer Inc. and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, NIH, and American Society of Nutrition during the conduct of the study. J.E.M. reports receiving investigator-initiated grants from Mars Edge and support from Pfizer Consumer Healthcare (now Haleon) for donation of COSMOS study pills and packaging during the conduct of the trial. M.L. reports grants from the National Institutes of Health during the conduct of this study and Amgen stock ownership unrelated to this study.

5.
Effects of daily multivitamin-multimineral supplementation on metabolomic profiles: 2-year findings from the COSMOS randomized clinical trial.
GeroScience 2026 PMID:41910928

2. Geroscience. 2026 Mar 30. doi: 10.1007/s11357-026-02197-9. Online ahead of print. Effects of daily multivitamin-multimineral supplementation on metabolomic profiles: 2-year findings from the COSMOS randomized clinical trial. Li S(#)(1)(2), Hamaya R(#)(2), Farukhi Z(2), Li J(2)(3), Rist PM(2)(4), Manson JE(2)(4)(5), Sesso HD(6)(7)(8). Author information: (1)Institute of Public Health Sciences, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China. (2)Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 900 Commonwealth Avenue East, Boston, MA, 02215, USA. (3)Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA. (4)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. (5)Brigham and Women's Hospital, Mary Horrigan Connors Center for Women's Health, Harvard Medical School, Boston, MA, USA. (6)Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 900 Commonwealth Avenue East, Boston, MA, 02215, USA. hsesso@bwh.harvard.edu. (7)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. hsesso@bwh.harvard.edu. (8)Division of Aging, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. hsesso@bwh.harvard.edu. (#)Contributed equally Despite widespread use in the USA, little is known about the impact of multivitamin-multimineral (MVM) supplementation on metabolomic profiles and how this may translate to biological aging and long-term risk of age-related chronic diseases. The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is a 2 × 2 factorial, placebo-controlled, double-blinded, randomized clinical trial testing daily MVM (Centrum Silver®) in US older adults. In 399 participants with metabolomics profiles quantified using the Nightingale Health nuclear magnetic resonance platform at baseline, year 1, and year 2 (70.3 ± 5.7 years; 50.1% female), we evaluate the effects of MVM versus placebo on 168 metabolites, 7 metabolomics clocks of biological aging, and 24 metabolomic risk scores (MRS) for chronic diseases. Compared with placebo, 2-year daily MVM supplementation increased the concentrations of docosahexaenoic acid (Cohen's d for between-group differences in changes from baseline to 2 years, 0.212 [95% CI, 0.02 to 0.404]) and omega-3 fatty acids (0.193 [0.003 to 0.382]) as well as delayed the increase in concentrations of creatinine (-0.222 [-0.424 to -0.019]). MVM also reduced MRS for 16 chronic diseases, including major cardiovascular events, renal disease, all-cause dementia, asthma, cataracts, glaucoma, liver disease, non-melanoma skin cancer, and prostate cancer (Cohen's d range, -0.206 to -0.277). However, all these effects were only significant at nominal levels, not after multiple-testing correction (p < 0.05; FDR > 0.05). Additionally, MVM led to a non-significant decrease across all metabolomic aging clocks, ranging from 0.496 to 1.054 years. Despite the limited sample size, COSMOS provides preliminary evidence that daily MVM supplementation may modestly improve metabolomic profiles in older adults. Further expansion within COSMOS is still warranted to confirm whether these alterations contribute to the benefits of MVM supplementation for healthy aging. Trial registration number: NCT02422745. © 2026. The Author(s), under exclusive licence to American Aging Association. DOI: 10.1007/s11357-026-02197-9 PMID: 41910928 Conflict of interest statement: Declarations. Ethics and consent to participate: All participants provided written informed consent before enrollment in the trial, and trial activities were overseen by the Human Subjects Committee at BWH/Mass General Brigham (2014P002768). Competing interests: Dr. Sesso received in-kind contributions from Nightingale Health for the included metabolomics assays. Drs. Manson and Sesso received investigator-initiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging, and Pfizer Consumer Healthcare (now Haleon) for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, and NIH during the conduct of the study. Dr. Rist received a donation of study pills and packaging from Mars Edge for use in an investigator-initiated NIH-funded trial. No other authors reported any conflicts of interest for this study.

6.
Effect of 2-Year Caloric Restriction in the Absence of Malnutrition on Indicators of Anemia, Iron Status, and Hepcidin in Healthy Adults: A Randomized Clinical Trial.
The Journal of nutrition 2026 PMID:41825741

3. J Nutr. 2026 Mar 11;156(5):101474. doi: 10.1016/j.tjnut.2026.101474. Online ahead of print. Effect of 2-Year Caloric Restriction in the Absence of Malnutrition on Indicators of Anemia, Iron Status, and Hepcidin in Healthy Adults: A Randomized Clinical Trial. Dugan C(1), Das SK(2), Racette SB(3), Martin CK(1), Ravussin E(1), Redman LM(1), Hennigar SR(4). Author information: (1)Pennington Biomedical Research Center, Baton Rouge, LA United States. (2)Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States. (3)College of Health Solutions, Arizona State University, Phoenix, AZ, United States. (4)Pennington Biomedical Research Center, Baton Rouge, LA United States. Electronic address: stephen.hennigar@pbrc.edu. BACKGROUND: Caloric restriction (CR) is a promising nutritional intervention for improving metabolic and age-related health outcomes, but its long-term effects on hematologic health remain unclear. Clarifying how prolonged CR affects anemia risk and iron status is essential for evaluating its long-term safety and clinical relevance. OBJECTIVES: To determine the effects of a 2-y CR intervention on markers of anemia, iron status, and hepcidin in females and males enrolled in the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE) Phase 2 trial. METHODS: Participants in CALERIE Phase 2 (n = 220) were randomly assigned to 25% CR or ad libitum (AL) control. AL continued their habitual diet, whereas CR received an intensive intervention to promote CR over 2 y. All participants received a multivitamin/mineral supplement containing 18 mg iron. Fasted blood was collected at baseline (BL) and 12 (M12) and 24 (M24) mo and indicators of iron status (ferritin, soluble transferrin receptor, and serum iron), anemia (hemoglobin and hematocrit), and regulators of iron status (hepcidin, C-reactive protein, and IL-6) were measured. Six-day diet diaries were collected twice at BL and once each at M12 and M24. An anemia surveillance protocol monitored hemoglobin, hematocrit, red blood cell (RBC) count, and serum iron throughout the intervention, with medical evaluation and temporary/permanent CR discontinuation as needed. Linear mixed-effects models were used to evaluate the effect of treatment (CR compared with AL), time (BL, M12, and M24), and their interaction (treatment × time). RESULTS: Participants (n = 218) were mostly female (70%) with an mean age (±SD) of 38.1 ± 7.2 y and a mean BMI of 25.2 ± 1.7 kg/m2. At baseline, ferritin (105.5 ± 126.9 μg/L), hepcidin (8.6 ± 5.8 ng/mL), and dietary iron intake (16.1 ± 5.5 mg/d) were similar between groups (P > 0.05). There were no group × time interactions for markers of anemia, indicators of iron status, or hepcidin (P > 0.05). Despite the anemia surveillance protocol, anemia prevalence remained >5% in both groups across all timepoints. Low RBC count was the most common trigger, and participants who triggered the protocol had lower hematocrit at M12 (P < 0.001) and M24 (P < 0.001); however, dietary iron intake remained similar and there were no differences in any indicators of iron status or hepcidin between those who triggered the protocol and those who did not. CONCLUSIONS: These findings suggest that prolonged CR in the absence of malnutrition does not adversely affect iron status or hepcidin in healthy adults. Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.tjnut.2026.101474 PMID: 41825741 Conflict of interest statement: Conflict of interest SRH is an Editorial Board Member for The Journal of Nutrition and played no role in the Journal’s evaluation of the manuscript. All other authors report no conflicts of interest.

7.
Effects of daily multivitamin-multimineral and cocoa extract supplementation on epigenetic aging clocks in the COSMOS randomized clinical trial.
Nature medicine 2026 PMID:41803341

4. Nat Med. 2026 Mar;32(3):1012-1022. doi: 10.1038/s41591-026-04239-3. Epub 2026 Mar 9. Effects of daily multivitamin-multimineral and cocoa extract supplementation on epigenetic aging clocks in the COSMOS randomized clinical trial. Li S(1)(2), Hamaya R(2), Zhu H(3), Chen BH(4), Pereira AC(5), Ivey KL(5), Rist PM(2)(6), Manson JE(2)(6)(7), Dong Y(3), Sesso HD(8)(9)(10). Author information: (1)Institute of Public Health Sciences, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China. (2)Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. (3)Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA, USA. (4)California Pacific Medical Center Research Institute, San Francisco, CA, USA. (5)Division of Aging, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. (6)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. (7)Mary Horrigan Connors Center for Women's Health Research, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. (8)Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. hsesso@bwh.harvard.edu. (9)Division of Aging, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. hsesso@bwh.harvard.edu. (10)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. hsesso@bwh.harvard.edu. Large-scale randomized trials have found that multivitamin-multimineral (MVM) supplements and cocoa flavanols may benefit several age-related chronic conditions among older adults, but it remains unclear whether these two supplements directly slow the biological aging process. This prespecified ancillary study evaluated the 2-year effect of a daily MVM (Centrum Silver) and cocoa extract (500 mg cocoa flavanols per day, including 80 mg (-)-epicatechin) on five DNA methylation measures of biological aging (PCHannum, PCHorvath, PCPhenoAge, PCGrimAge and DunedinPACE) among 958 participants (482 women and 476 men) in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). Compared with placebo, daily MVM supplementation modestly reduced the rate of increase of second-generation epigenetic clocks, with a between-group difference in yearly change of -0.113 years (95% confidence interval (CI) -0.205 to -0.020; P = 0.017) for PCGrimAge and -0.214 years (-0.410 to -0.019; P = 0.032) for PCPhenoAge. MVM had a stronger effect on PCGrimAge among those with accelerated biological aging at baseline (-0.236 [-0.380 to -0.091]) compared with those with normal or decelerated biological aging (-0.013 [-0.130 to 0.104]; P = 0.018 for interaction). Cocoa extract did not have an effect on the five epigenetic clocks tested. Although the statistically significant but small effects of daily MVM supplementation on slowing biological aging are encouraging, additional studies are needed to determine the clinical relevance of daily MVM supplementation on epigenetic clocks and whether such effects can help explain the beneficial effects of MVM supplementation on aging-related chronic conditions. © 2026. The Author(s), under exclusive licence to Springer Nature America, Inc. DOI: 10.1038/s41591-026-04239-3 PMID: 41803341 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: J.E.M. and H.D.S. received investigator-initiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging, and Pfizer Consumer Healthcare (now Haleon) for donation of COSMOS study pills and packaging during the conduct of the study. H.D.S. additionally received investigator-initiated grants from FOXO Technologies, Massachusetts Life Sciences Center, Pure Encapsulations, American Pistachio Growers and Haleon, and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, Haleon and NIH during the conduct of the study. P.M.R. has received in-kind support (specifically donations of study pills and packaging) from Mars Edge to be used in an NIH-funded, investigator-initiated trial (U01 AT012611 ). B.H.C. was formerly an employee of FOXO Technologies, who provided in-kind donations to generate and preprocess the DNA methylation data. S.L. received the EPI Early Career Travel Grant sponsored by the Council on Epidemiology and Prevention’s Early Career Committee, American Heart Association. The other authors declare no competing interests.

8.
Effects of Randomized Multivitamin Supplementation on Carotenoids and α-Tocopherol in the COcoa Supplement and Multivitamin Outcomes Study.
Journal of the Academy of Nutrition and Dietetics 2026 PMID:41587736

5. J Acad Nutr Diet. 2026 May;126(5):156299. doi: 10.1016/j.jand.2026.156299. Epub 2026 Jan 24. Effects of Randomized Multivitamin Supplementation on Carotenoids and α-Tocopherol in the COcoa Supplement and Multivitamin Outcomes Study. Christopher CN(1), Erdman JW Jr(2), Kim E(3), Black M(2), Rist PM(4), Tobias DK(5), Rautiainen S(6), Manson JE(4), Sesso HD(4). Author information: (1)Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. Electronic address: cchristopher@fas.harvard.edu. (2)Division of Nutritional Sciences and Beckman Institute, Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, Urbana, Illinois. (3)Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. (4)Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. (5)Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. (6)Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden; Division of Obstetrics, Department of Women's Health, Karolinska University Hospital, Stockholm, Sweden. BACKGROUND: Adequate intake of carotenoids and vitamin E supports healthy aging, yet evidence is limited on whether multivitamin-multimineral (MVM) supplementation changes serum concentrations over time. OBJECTIVE: The aim of this investigation was to evaluate the effect of daily MVM supplementation among older adults on serum carotenoid and vitamin E concentrations over a 2-year period. DESIGN: The COcoa Supplement and Multivitamin Outcomes Study is a large-scale, randomized, placebo-controlled, 2 × 2 factorial trial, designed to test the effects of daily MVM and cocoa extract supplementation for chronic disease prevention. Participants completed semiannual questionnaires and provided optional biospecimen samples at baseline, 1-year, and 2-year follow-up. PARTICIPANTS AND SETTING: Between 2015 and 2020, US adults (women aged 65 years and older, men aged 60 years and older) without major cardiovascular disease or recent cancer were enrolled in the COcoa Supplement and Multivitamin Outcomes Study. This analysis included biospecimen substudy participants with blood samples provided at baseline and ≥1 follow-up timepoint (n = 400; 1 excluded due to unusable sample; final N = 399). INTERVENTION: Participants were randomized to receive daily MVM supplementation or a placebo, with or without cocoa extract. MAIN OUTCOME MEASURES: Changes in serum carotenoids and α-tocopherol concentrations were evaluated over the 2-year follow-up. STATISTICAL ANALYSES: Multivariable linear mixed models estimated changes in serum biomarker concentrations, comparing MVM with placebo, adjusting for covariates (age, sex, and cocoa extract intervention). RESULTS: Increases in serum carotenoids and α-tocopherol levels with MVM supplementation emerged at year 1 and persisted through year 2. MVM supplementation led to significantly higher serum concentrations of total carotenoids (percent change: 15.5%; 95% CI, 8.72 to 22.70), lutein (percent change: 17.17%; 95% CI, 7.53 to 27.66), beta carotene (percent change: 46.96%; 95% CI, 35.10 to 59.85), and α-tocopherol (percent change: 29.50%; 95% CI, 22.88 to 36.47) over 2 years compared with placebo. No significant differences were observed for lycopene, β-cryptoxanthin, zeaxanthin, or α-carotene. Cocoa extract supplementation did not modify the effect of MVM on serum carotenoid and vitamin E levels (P ≥ .05). CONCLUSIONS: Daily MVM supplementation increased specific serum carotenoids and α-tocopherol concentrations over 2 years. These findings suggest regular MVM use may support nutritional status in older adults; future research is needed to examine links with aging-related outcomes. Copyright © 2026 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.jand.2026.156299 PMCID: PMC13075385 PMID: 41587736 [Indexed for MEDLINE] Conflict of interest statement: CONFLICTS OF INTEREST: HDS and JEM reported receiving investigator-initiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging, and Pfizer Consumer Healthcare (now Haleon) for donation of COSMOS study pills and packaging during the conduct of the study. The other authors report no conflicts of interest.

9.
Multivitamin supplements are not superior to nutrition education in improving fat-soluble vitamin levels: A double-blind randomized controlled trial.
Asia Pacific journal of clinical nutrition 2026 PMID:41565231

6. Asia Pac J Clin Nutr. 2026 Feb;35(1):52-59. doi: 10.6133/apjcn.202602_35(1).0005. Multivitamin supplements are not superior to nutrition education in improving fat-soluble vitamin levels: A double-blind randomized controlled trial. Yusupu S(#)(1)(2), Yang Y(#)(3), Geng X(1), Lin Z(1), Sun T(1), Wang Z(1), Lu H(4), Deng Y(5). Author information: (1)Zhuhai Precision Medical Center, Guangdong Provincial Key Laboratory of Tumor Interventional Diagnosis and Treatment, Zhuhai People's Hospital (Zhuhai Clinical Medical College of Jinan University), Zhuhai, China. (2)Department of Endocrinology and Metabolism, Zhuhai People's Hospital (Zhuhai Clinical Medical College of Jinan University), Zhuhai, China. (3)School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China. (4)Department of Endocrinology and Metabolism, Zhuhai People's Hospital (Zhuhai Clinical Medical College of Jinan University), Zhuhai, China. Email: luhongyun@jnu.edu.cn. (5)Zhuhai Precision Medical Center, Guangdong Provincial Key Laboratory of Tumor Interventional Diagnosis and Treatment, Zhuhai People's Hospital (Zhuhai Clinical Medical College of Jinan University), Zhuhai, China. Email: Yaodeng030@ext.jnu.edu.cn. (#)Contributed equally BACKGROUND AND OBJECTIVES: Vitamin deficiencies are closely associated with the development of chronic diseases. Therefore, effective and safe intervention strategies are critical to improving vitamin nutritional status. This study aimed to assess the effectiveness and differential impacts of nutrition education and multi-vitamin supplementation, providing a basis for selecting safer intervention strategies. METHODS AND STUDY DESIGN: A 4-week, double-blind, randomized controlled trial was conducted among 155 adults (aged 18-65 years) with confirmed deficiencies in fat-soluble vitamins (A, D, or E). Participants were randomly assigned to receive either nutrition education with a multivitamin supplement or nutrition education with placebo. The concentrations of fat-soluble vitamins (A, D, or E), as well as their deficiency rates, were compared before and after the intervention. RESULTS: A total of 155 participants completed the study. There were no significant differences in demographic characteristics between the two groups. In both groups, the concentration of vitamins (A, D, or E) significantly increased (all p < 0.001), and the deficiency rates for all three vitamins significantly decreased (all p < 0.001). However, there were no significant differences in the concentrations or deficiency rates of vitamins (A, D, or E) between the two groups after intervention (all p > 0.05). CONCLUSIONS: Multivitamin supplements are not superior to nutrition education. Nutrition education alone may be a safer and effective approach to addressing deficiencies in vitamins A, D, and E, while reducing the risks as-sociated with unnecessary vitamin supplementation in the general population. DOI: 10.6133/apjcn.202602_35(1).0005 PMCID: PMC12823257 PMID: 41565231 [Indexed for MEDLINE] Conflict of interest statement: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest

10.
Feasibility of a randomized clinical trial comparing 5-methyltetrahydrofolate and folic acid prenatal multivitamins in couples with recurrent pregnancy loss.
Nutrition research (New York, N.Y.) 2026 PMID:41544303

7. Nutr Res. 2026 Feb;146:68-81. doi: 10.1016/j.nutres.2025.12.008. Epub 2025 Dec 19. Feasibility of a randomized clinical trial comparing 5-methyltetrahydrofolate and folic acid prenatal multivitamins in couples with recurrent pregnancy loss. Ledowsky C(1), Scarf V(2), Rogers K(3), Steel A(3). Author information: (1)School of Public Health, University of Technology Sydney, Ultimo, Australia. Electronic address: Carolyn.j.ledowsky@student.uts.edu.au. (2)School of Nursing and Midwifery, University of Technology Sydney, Australia. (3)School of Public Health, University of Technology Sydney, Ultimo, Australia. To assess the feasibility of a randomized controlled trial (RCT) comparing 5-methyltetrahydrofolate (5-MTHF) and folic acid (FA) in couples with recurrent pregnancy loss. Pregnancy loss affects up to 15% of pregnancies, with over half of cases remaining unexplained. Emerging evidence suggests that folate metabolism, particularly in individuals carrying methylenetetrahydrofolate reductase polymorphisms such as C677T and A1298C variants, may influence reproductive outcomes. A double-blind, RCT feasibility trial was conducted in Australia with 22 reproductive dyads randomized to receive either 5-MTHF or FA prenatal multivitamins. Participants adhered to dietary restrictions, abstained from conception for two cycles, and completed regular assessments. Primary outcomes included feasibility, adherence, acceptability, and preliminary efficacy based on biochemical markers and pregnancy outcomes. The trial demonstrated high acceptability (86% in arm A [MTHF-A] and 94% in arm B [FA-B]) and adherence rates for supplement use over 78% in each arm. Unmetabolized FA concentration decreased in the 5-MTHF group but rose significantly in the FA group. A critical finding was the degradation of 5-MTHF in retained samples, highlighting formulation instability as a confounder. A fully online RCT comparing 5-MTHF and FA is feasible. Future trials should address formulation stability and expand sample size to evaluate clinical efficacy and personalized folate strategies. Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.nutres.2025.12.008 PMID: 41544303 [Indexed for MEDLINE] Conflict of interest statement: Author declarations Carolyn Ledowsky reports financial support was provided by Balchem Corp. Carolyn Ledowsky reports equipment, drugs, or supplies were provided by Balchem Corp. Carolyn Ledowsky reports equipment, drugs, or supplies was provided by Aprofol AG. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article.

11.
Effects of multivitamin combined with magnesium sulfate versus magnesium sulfate alone on hemodynamics, coagulation, and maternal-infant outcomes in preeclampsia: a randomized controlled study.
Journal of health, population, and nutrition 2025 PMID:41476304

8. J Health Popul Nutr. 2025 Dec 31;45(1):41. doi: 10.1186/s41043-025-01199-1. Effects of multivitamin combined with magnesium sulfate versus magnesium sulfate alone on hemodynamics, coagulation, and maternal-infant outcomes in preeclampsia: a randomized controlled study. Gao S(1), Ming J(2), Sun F(3), Zhao H(3), Chen L(4), Wan J(3), Yu Y(3). Author information: (1)Obstetrics Department, West Coast Branch, the Affiliated Hospital of Qingdao University, No.1677, Wutaishan Road, Qingdao, 266500, China. gaoshaobo0307@163.com. (2)Oncology Department, West Coast Branch, the Affiliated Hospital of Qingdao University, Qingdao, 266500, China. (3)Obstetrics Department, West Coast Branch, the Affiliated Hospital of Qingdao University, No.1677, Wutaishan Road, Qingdao, 266500, China. (4)Nursing Department, West Coast Branch, the Affiliated Hospital of Qingdao University, Qingdao, 266500, China. OBJECTIVE: To explore the effects of multivitamin combined with magnesium sulfate on placental hemodynamics, coagulation function, and maternal and infant outcomes in preeclampsia patients. METHODS: A randomized controlled study was conducted among 194 pregnant women diagnosed with preeclampsia between April 2022 and April 2023. Participants were randomly assigned to either the control group (n = 97), receiving intravenous magnesium sulfate alone, or the observation group (n = 97), receiving magnesium sulfate combined with multivitamin supplementation. Magnesium sulfate was administered with a loading dose of 2.5-5 g via rapid IV infusion and a maintenance dose of 5-20 g by continuous drip. The observation group additionally received one oral multivitamin tablet (Bayer S.A., 30 tablets/box) once daily in the morning. The treatment duration for both groups was two weeks. Blood pressure, 24-hour urinary protein, placental Doppler indices (RI, PI, S/D), coagulation markers (PT, APTT, FIB, TT), and maternal-infant outcomes were measured and compared. RESULTS: After treatment, both groups showed significant reductions in systolic and diastolic blood pressure, but there was no significant difference between them. However, the observation group had significantly lower 24-hour urinary protein levels (0.71 ± 0.31 g vs. 0.92 ± 0.28 g, P < 0.001). Coagulation function improved in both groups, with the observation group showing greater improvements: longer PT, APTT, and TT times, and lower FIB levels (P < 0.01). Placental hemodynamics also improved more in the observation group, with lower resistance indices and S/D ratios in both the umbilical and spiral arteries (P < 0.001). The observation group had better maternal and neonatal outcomes, including fewer cases of postpartum hemorrhage (10 vs. 22, P = 0.020), low birth weight (10 vs. 23, P = 0.013), and NICU admissions (9 vs. 21, P = 0.018). Eclampsia occurred only in the control group (3 cases), though this was not statistically significant (P = 0.081). Other outcomes, such as uterine inertia and neonatal asphyxia, were similar between groups. Subgroup analysis showed that patients with severe preeclampsia in the observation group experienced greater improvements in proteinuria and placental blood flow than those in the control group. Cesarean section rates were comparable (58 vs. 62), with main indications including fetal distress, failed labor, and poorly controlled PE. Logistic regression confirmed that multivitamin use was an independent factor for better outcomes (OR = 3.297; 95% CI: 1.731-6.282; P < 0.001), regardless of age, BMI, or gestational age. CONCLUSION: Multivitamin supplementation combined with magnesium sulfate improves outcomes in preeclampsia more effectively than magnesium sulfate alone. It reduces proteinuria, enhances placental blood flow and coagulation function, and lowers the risk of complications such as postpartum hemorrhage, low birth weight, and NICU admission. These benefits are particularly notable in severe cases and are independent of baseline maternal factors, supporting the use of combined therapy in clinical practice. © 2025. The Author(s). DOI: 10.1186/s41043-025-01199-1 PMCID: PMC12866340 PMID: 41476304 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Ethics approval: All procedures performed in studies involving human participants were in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study is approved by the Ethics Committee of [Qingdao University Affiliated Hospital], approval number [QYFY WZLL 30210]. Written informed consent was obtained. Consent for publication: Informed consent was obtained from all individual participants included in the study. Competing interests: The authors declare no competing interests.

12.
Investigating the Effect of Synbiotic and SperiGen Supplementations on Spermatogram in Idiopathic Oligoasthenoteratozoospermia: A Double-Blinded Randomized Clinical Trial.
International journal of urology : official journal of the Japanese Urological Association 2026 PMID:41387285

9. Int J Urol. 2026 Jan;33(1):e70255. doi: 10.1111/iju.70255. Epub 2025 Dec 12. Investigating the Effect of Synbiotic and SperiGen Supplementations on Spermatogram in Idiopathic Oligoasthenoteratozoospermia: A Double-Blinded Randomized Clinical Trial. Zarehoroki A(1), Vahidi S(1)(2), Sahebnasagh A(3), Shahsavan R(4), Nabi A(2)(5), Meybodi MN(6), Saghafi F(7). Author information: (1)Department of Urology, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. (2)Andrology Research Center, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. (3)Department of Internal Medicine, Clinical Research Center, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran. (4)Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Student Research Committee, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. (5)Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. (6)Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. (7)Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. BACKGROUND: Male infertility is influenced by a variety of etiologies, including quantitative and qualitative impairments in spermatogenesis. Antioxidants scavenge reactive oxygen species (ROS), which reduce sperm motility, cause damage to DNA, and lead to subsequent apoptosis in sperm cells. This trial aimed to evaluate the effect of oral Synbiotic and a multivitamin-mineral supplement for men helping to improve male fertility (SperiGen), as an antioxidant agent, on the spermatogram in idiopathic Oligoasthenoteratozoospermia (iOAT). MATERIALS AND METHODS: This double-blind randomized clinical trial was conducted on infertile males with iOAT. Totally, 73 patients with iOAT were blindly randomized into two groups; one group received SperiGen as an antioxidant agent in addition to placebo. In the next group, in addition to SperiGen, the patients received 500 mg Synbiotic (FamiLact) on a daily basis. They continued their treatments for 3 months. Semen parameters were measured before and after the intervention. RESULTS: Supplementations with a combination of Synbiotic and SperiGen compared with SperiGen and placebo significantly increased the average change of sperm progressive motility (p = 0.001), DNA fragmentation (p = 0.001), and diminished the levels of non-motile sperm (p = 0.018). Eventually, within-group analysis indicated that all parameters were significantly improved in both groups, except for non-progressive motility in the SperiGen and placebo group. CONCLUSION: The combination of Synbiotic and SperiGen (an antioxidant supplement) appears to be much more effective than using an antioxidant alone in improving the DNA fragmentation, concentration, and progressive motility of sperm. TRIAL REGISTRATION: IRCT20190810044500N6, 2020-09-05. https://irct.behdasht.gov.ir/trial/46773. https://trial.medpath.com/clinical-trial/7ad7a7af5cba37f3/evaluating-symbiotic-therapy-male-infertility. © 2026 The Japanese Urological Association. DOI: 10.1111/iju.70255 PMID: 41387285 [Indexed for MEDLINE]

13.
Long-Term Effect of Multivitamin Supplementation on Incident Self-Reported Hypertension and Blood Pressure Changes in the COSMOS Trial.
American journal of hypertension 2026 PMID:41264477

10. Am J Hypertens. 2026 Apr 1;39(4):538-546. doi: 10.1093/ajh/hpaf224. Long-Term Effect of Multivitamin Supplementation on Incident Self-Reported Hypertension and Blood Pressure Changes in the COSMOS Trial. Hamaya R(1), Li S(1), Lau J(1), Rautiainen S(2), Haring B(3)(4)(5), Liu S(6)(7)(8), Shadyab AH(9)(10), Martin LW(11), Wassertheil-Smoller S(12), Rist PM(1)(13), Manson JE(1)(13), Sesso HD(1)(13); COSMOS Research Group. Collaborators: Hamaya R, Li S, Lau J, Rautiainen S, Haring B, Liu S, Shadyab AH, Martin LW, Wassertheil-Smoller S, Rist PM, Manson JE, Sesso HD. Author information: (1)Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States. (2)Clinical Epidemiology Division, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden. (3)Department of Medicine IV, Clinic Hietzing, Vienna, Austria. (4)Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY, United States. (5)HOMICAREM (HOMburg Institute for CArdioREnalMetabolic Medicine), Saarland University, Homburg/Saar, Germany. (6)Department of Epidemiology & Biostatistics, Joe Wen School of Population & Public Health, University of California, Irvine, Irvine, CA, United States. (7)Mary & Steve Wen Cardiovascular Division, Department of Medicine, School of Medicine, University of California, Irvine, Irvine, CA, United States. (8)Center for Global Cardiometabolic Health & Nutrition, Susan & Henry Samueli College of Health Sciences, University of California, Irvine, Irvine, CA, United States. (9)Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, CA, United States. (10)Division of Geriatrics, Gerontology, and Palliative Care, Department of Medicine, University of California San Diego, La Jolla, CA, United States. (11)School of Medicine and Health Sciences, George Washington University, Washington, DC, United States. (12)Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States. (13)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, United States. Comment in Am J Hypertens. 2026 Apr 1;39(4):491-493. doi: 10.1093/ajh/hpaf242. BACKGROUND: Multivitamin-multimineral (MVM) supplements have been associated with lower blood pressure (BP) in several small trials. We investigated the effects of a MVM on incident hypertension and BP in a secondary analysis of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). METHODS: COSMOS is a 2×2 factorial, double-blinded RCT testing effects of cocoa extract and MVM supplementation among women aged ≥65 years and men aged ≥60 years. Among 8905 COSMOS participants free from hypertension, effects of MVM supplementation on incident hypertension were investigated. Hypertension diagnosis was ascertained through self-reports. Additionally, in two substudies with BP measurements (N = 529 at clinic by research staff and 994 at home by technician), we evaluated the effects on 2-year BP changes. RESULTS: Incident hypertension was observed in N = 1034 (22.9%) in MVM arm and N = 1039 (23.6%) in placebo arm over a median of 3.4 years (IQR: 3.0, 3.9) of follow-up, with hazard ratio (HR) 0.98 [95% CI: 0.90, 1.06]. Effects differed according to baseline diet quality, with HRs of incident hypertension 0.81 [0.70, 0.95] and 1.14 [1.01, 1.28] among participants with lower and higher Alternate Mediterranean Diet score, respectively (P-interaction = .001). There was no effect of MVM on 2-year changes in systolic BP (4.4 mmHg in MVM; 4.5 mmHg in placebo), while pronounced effects were observed for baseline normal BP (P-interaction = .004). CONCLUSIONS: MVM supplementation versus placebo did not reduce hypertension incidence or lower BP overall. Exploratory analyses showed greater reduction in hypertension risk and BP changes among those with lower dietary quality and normal BP at baseline, respectively. CLINICAL TRIAL REGISTRATION: NCT02422745. © The Author(s) 2025. Published by Oxford University Press on behalf of American Journal of Hypertension, Ltd. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. DOI: 10.1093/ajh/hpaf224 PMCID: PMC13017768 PMID: 41264477 [Indexed for MEDLINE] Conflict of interest statement: H.D.S. and J.E.M. received investigator-initiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging, and Pfizer Consumer Healthcare (now Haleon) for donation of COSMOS study pills and packaging during the conduct of the study. H.D.S. additionally reported receiving investigator-initiated grants from Pure Encapsulations and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, and NIH during the conduct of the study. No other authors reported any conflicts of interests for this study.

14.
A pilot and feasibility analysis of serum TMAO and choline in a randomized sample from the COSMOS trial.
Food & function 2025 PMID:41127993

11. Food Funct. 2025 Nov 10;16(22):8791-8800. doi: 10.1039/d5fo02596f. A pilot and feasibility analysis of serum TMAO and choline in a randomized sample from the COSMOS trial. Gavilán IS(1)(2), Li S(1), Sweet MG(3), Ratliff JG(3), Rist PM(1)(4), Kim E(1), Manson JE(1)(4), Sesso HD(1)(4), Neilson AP(3)(5). Author information: (1)Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. hsesso@bwh.harvard.edu. (2)Real Colegio Complutense at Harvard University, Cambridge, MA, USA. (3)Plants for Human Health Institute, North Carolina State University, Kannapolis, NC, USA. aneilso@ncsu.edu. (4)Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. (5)Department of Food, Bioprocessing and Nutrition Science, North Carolina State University, Raleigh, NC, USA. Objective: The metabolite trimethylamine N-oxide (TMAO) is a biomarker influenced by diet and linked to atherosclerosis, thrombosis, and cardiovascular disease (CVD). Choline is a crucial nutrient involved in maintaining cell structure, promoting liver health, and neurotransmission. However, human evidence is limited whether cocoa extract (CE) changes TMAO and choline levels over time. The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is a randomized, placebo-controlled, 2 × 2 factorial trial testing a CE supplement (containing 500 mg d-1 flavanols) and a daily multivitamin for chronic disease prevention in 21 442 older adults. We conducted a pilot study of the impact of CE on 1 year changes in TMAO and choline in COSMOS participants to facilitate sample size calculations for larger analyses of this trial in the future. In a pilot intention to treat analyses, linear mixed effect models were used to explore serum TMAO and choline trajectories in relation to CE assignment, adjusting for age, sex, and the other randomization arm. Methods: We randomly selected 40 COSMOS participants with blood samples at baseline and year 1. TMAO and choline were measured in plasma samples by liquid chromatography with stable isotope dilution tandem mass spectrometry. We excluded 3 of 40 participants due to extreme TMAO values ≥32.9 μM. Results: The mean age at baseline was 77 ± (5.5) years, and 18 (48.7%) were female. Randomization successfully distributed baseline demographic, clinical, behavioral, and dietary characteristics by treatment group. Among the 37 COSMOS participants, those assigned to take a CE supplement, as compared to placebo, had similar TMAO and choline levels at baseline but showed trends toward lower levels of TMAO (-0.60 [95% CI, (-3.76, 2.55)]) at 1 year. However, the between-group differences in the 1 year changes in TMAO (CE minus placebo) were not statistically significant (-1.16 [95% CI, (-5.81, 3.50)]; P = 0.62). In contrast, the group assigned CE showed trends toward higher levels of choline (0.84 (-1.57, 3.25)) at year 1, but the between-group differences in the 1 year changes in choline were again not statistically significant (2.23 [95% CI, (-1.31, 5.78)]; P = 0.21). Based on this pilot study, an expanded analysis of 1500 COSMOS participants would have 84% power to detect a 1.5 μM difference in TMAO levels comparing cocoa extract versus placebo. Conclusions: We measured TMAO and choline from stored blood samples in this pilot study from the COSMOS trial. Although daily CE supplementation was not associated with statistically significant 1 year changes in TMAO or choline levels, our sample size was limited. Larger studies are needed to understand whether TMAO and/or choline contribute to the reduction in CVD death observed with CE supplementation. DOI: 10.1039/d5fo02596f PMID: 41127993 [Indexed for MEDLINE]

15.
Effects of 2-year cocoa extract supplementation on inflammaging biomarkers in older US adults: findings from the COcoa Supplement and Multivitamin Outcomes Study randomised clinical trial.
Age and ageing 2025 PMID:40966617

12. Age Ageing. 2025 Aug 29;54(9):afaf269. doi: 10.1093/ageing/afaf269. Effects of 2-year cocoa extract supplementation on inflammaging biomarkers in older US adults: findings from the COcoa Supplement and Multivitamin Outcomes Study randomised clinical trial. Li S(1)(2), Hamaya R(2)(3), Zhu H(4), Clar A(2), Rist PM(2)(3), Huang Y(4), Manson JE(2)(3), Sesso HD(2)(3), Dong Y(4). Author information: (1)University of Science and Technology of China, Institute of Public Health Sciences, Division of Life Sciences and Medicine, Hefei, Anhui, China. (2)Brigham and Women's Hospital, Division of Preventive Medicine, Boston, MA, USA. (3)Harvard T.H. Chan School of Public Health, Department of Epidemiology, Boston, MA, USA. (4)Augusta University, Georgia Prevention Institute, Medical College of Georgia, Augusta, GA, USA. OBJECTIVE: To examine the long-term effect of cocoa flavanols on inflammaging biomarkers in the COcoa Supplement and Multivitamin Outcomes Study (COSMOS). METHODS: COSMOS is a large, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial testing the effects of a cocoa extract supplement (containing 500 mg cocoa flavanols/day, including 80 mg (-)-epicatechin) among women aged ≥65 years and men aged ≥60 years. This ancillary study measured five widely used serum inflammaging biomarkers, including three pro-inflammatory markers (high-sensitivity C-reactive protein [hsCRP], interleukin-6, tumour necrosis factor-α), one anti-inflammatory cytokine (interleukin-10) and one pleotropic cytokine (interferon-γ [IFN-γ]) in a random sample of 598 participants with biospecimens collected at baseline, Year 1, and Year 2. RESULTS: The mean age was 70.0 ± 5.6 years, and 49.8% were female. Cocoa extract supplementation significantly decreased hsCRP levels compared with placebo, with a between-group difference in yearly percentage change relative to baseline levels of -8.4% (95% CI, -14.1% to -2.3%; nominal P = .008; Holm-adjusted P value = .039). Moreover, cocoa extract increased IFN-γ with a 6.8% (95% CI, 1.5% to 12.2%, nominal P = .011; Holm-adjusted P value = .043) difference in yearly percentage change versus placebo. The effects of cocoa extract on other inflammatory markers were not significant (all adjusted P values >.05). CONCLUSION: Cocoa extract supplementation significantly decreased hsCRP, supporting a role in modulating the chronic inflammaging process as a potential mechanism underlying its cardio-protective effects, including a 27% reduction in cardiovascular disease death in the COSMOS trial. The biological effect of increased IFN-γ by cocoa extract warrants further exploration. © The Author(s) 2025. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. DOI: 10.1093/ageing/afaf269 PMCID: PMC12449576 PMID: 40966617 [Indexed for MEDLINE] Conflict of interest statement: Drs. Manson and Sesso received investigator-initiated grants from Mars Edge, a segment of Mars Incorporated dedicated to nutrition research and products, for infrastructure support and donation of COSMOS study pills and packaging, and Pfizer Consumer Healthcare for donation of COSMOS study pills and packaging during the conduct of the study. Dr. Sesso additionally reported receiving investigator-initiated grants from Pure Encapsulations, American Pistachio Growers and Haleon, and honoraria and/or travel for lectures from the Council for Responsible Nutrition, BASF, Haleon and NIH during the conduct of the study. No other authors reported any conflicts of interests for this study.

16.
Effects of Lactiplantibacillus plantarum DSM 33464 in children with elevated blood lead levels: a randomized, double-blind, placebo-controlled study.
Frontiers in nutrition 2025 PMID:40959702

13. Front Nutr. 2025 Sep 1;12:1641839. doi: 10.3389/fnut.2025.1641839. eCollection 2025. Effects of Lactiplantibacillus plantarum DSM 33464 in children with elevated blood lead levels: a randomized, double-blind, placebo-controlled study. Ji W(#)(1), Saulnier DM(#)(2), Zhang L(3), Liu J(4), Gao J(5), Wang X(6), Holz C(2), Liang A(1), Tan HT(7). Author information: (1)Department of Children's Health Care Center, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China. (2)Novozymes Berlin GmbH, Berlin, Germany. (3)Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China. (4)Baoding Children's Hospital, Baoding, China. (5)Xuzhou Children's Hospital, Xuzhou, China. (6)Children's Hospital of Hebei Province, Hebei, China. (7)Novonesis, Cork, Ireland. (#)Contributed equally INTRODUCTION: Approximately one-third of the world's children have elevated blood lead levels (BLLs), which may lead to often-irreversible decreased intelligence, behavioral difficulties, and learning problems. Identification and removal of the source of lead, along with good nutrition, are the only advocated initial management, with chelation therapy for higher threshold BLLs. Probiotics have shown promising beneficial effects pre-clinically. Here, we investigated the safety and efficacy of the probiotic Lactiplantibacillus plantarum DSM 33464 in children with elevated blood lead levels. METHODS: Children aged 3-12 years with elevated BLLs (>3.5 μg/dL) were enrolled in a randomized double-blind placebo-controlled multi-centered study and received either probiotic (1 × 109) colony-forming units (CFUs) or placebo (control group), along with a multivitamin/mineral supplement in both groups daily for 12 weeks. RESULTS: Overall, 66 children were randomized, 54 received intervention (probiotic; n = 30 and control; n = 24). The probiotic was well-tolerated. Probiotics, combined with a multivitamin/mineral supplement, significantly reduced the BLLs in these children within 12 weeks of supplementation by 40%, similar to that of the control group, which received a placebo plus multivitamin/mineral supplement. A larger reduction in urine lead levels at 8 weeks was observed in the probiotic group, along with a reduction of abdominal pain and psychosomatic feelings at week 12. No depletion of essential minerals was observed in any of the groups. CONCLUSION: This study adds to previous findings suggesting that probiotic intervention may be a promising additional strategy to help reduce BLLs and their detrimental effects in children. Due to the preliminary nature of this study, larger studies investigating the effects of the strain alone, with a longer intervention period, are warranted to confirm the benefits observed. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT04891666. Copyright © 2025 Ji, Saulnier, Zhang, Liu, Gao, Wang, Holz, Liang and Tan. DOI: 10.3389/fnut.2025.1641839 PMCID: PMC12434113 PMID: 40959702 Conflict of interest statement: SmartGuard™ is a trademark of Novozymes A/S, part of Novonesis Group. DS, CH, H-TT are employees of Novonesis. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

17.
Maternal Adiposity and Inflammation: Risk Factors for Iron Deficiency in Pregnancy.
The Journal of nutrition 2025 PMID:40886951

14. J Nutr. 2025 Nov;155(11):3908-3923. doi: 10.1016/j.tjnut.2025.08.022. Epub 2025 Aug 29. Maternal Adiposity and Inflammation: Risk Factors for Iron Deficiency in Pregnancy. Demirdjian SP(1), Mulhern MS(1), Kerr MA(1), Ledwidge M(2), Alhomaid RM(3), Thompson PD(1), McCann MT(4). Author information: (1)Nutrition Innovation Centre for Food and Health, School of Biomedical Sciences, Ulster University, Coleraine, Northern Ireland. (2)School of Medicine, University College Dublin, Ireland. (3)Department of Food Science and Human Nutrition, College of Agriculture and Food, Qassim University, Buraydah, Saudi Arabia. (4)Nutrition Innovation Centre for Food and Health, School of Biomedical Sciences, Ulster University, Coleraine, Northern Ireland. Electronic address: mt.mccann@ulster.ac.uk. BACKGROUND: Obesity and iron deficiency (ID) are global health concerns in pregnancy, with serious consequences for mother and offspring. The inflammatory state associated with obesity and its potential contribution to ID/anemia is unclear. OBJECTIVES: This study aims to investigate the associations among maternal adiposity, the mediating role of inflammation, and iron status. We also aim to examine how adiposity affects the predictive accuracy of early pregnancy iron markers for late pregnancy ID risk. METHODS: This secondary analysis of a double-blind randomized controlled trial included singleton pregnancies supplemented with a multivitamin containing 17 mg/d of iron. Body mass index (BMI), body composition [12 gestational weeks (GW)], iron markers (12, 28, 36 GW), and hemoglobin/hematological indices (12, 28 GW, postpartum) were assessed. Proinflammatory cytokines were used to calculate an inflammation score and categorized as high/low inflammation. RESULTS: A total of 125 pregnant women were included: 43 normal weight, 44 overweight, and 38 with obesity. At 36 GW, ID was present in 50% of women with obesity, 40.9% of those overweight, and 30.2% with normal BMI. High BMI and fat mass index (FMI) at 12 GW predicted lower ferritin at 36 GW (BMI β = -0.253, P = 0.020; FMI β = -0.265, P = 0.010), and all adiposity measures predicted higher soluble transferrin receptor (sTfR). Transferrin saturation was lower in women with obesity at 12 and 28 GW (12 GW 23.9%, 24.5%, 30.3%, P = 0.016; 28 GW 13.2%, 17.7%, 17.2% P < 0.001, obesity, overweight, and normal weight, respectively). At 36 GW, pregnant women with obesity and higher inflammation score had lower ferritin than normal weight women (15.0 compared with 20.3 μg/L, P = 0.041). sTfR at 12 GW was the best predictor of ID at 36 GW [area under curve (AUC) = 0.738, P < 0.001], especially in overweight/obesity (AUC = 0.744, P < 0.001). CONCLUSIONS: High adiposity, mediated by inflammation, increases the risk of ID in the late third trimester. sTfR in early pregnancy emerges as an effective marker for predicting ID in late pregnancy. Copyright © 2025 The Author(s). Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.tjnut.2025.08.022 PMCID: PMC12799426 PMID: 40886951 [Indexed for MEDLINE] Conflict of interest statement: Conflict of interest MTM, MSM and MAK report financial support was provided by Solvotrin Therapeutics. MTM, MSM and MAK report a relationship with Solvotrin Therapeutics that includes: funding grants. ML reports a relationship with Solvotrin Therapeutics that includes: board membership, equity or stocks, and funding grants. ML has patent #WO2017158030A1 Compositions and methods for increasing iron intake in a mammal issued to Trinity College Dublin and Solvotrin Therapeutics. All other authors, declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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