루테인+제아잔틴 (AREDS2)
Lutein + Zeaxanthin (AREDS2)
📚 관련 논문 (18편)
1. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD000254. doi: 10.1002/14651858.CD000254.pub4. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Evans JR(1), Lawrenson JG. Author information: (1)Cochrane Eyes and Vision, ICEH, London Sc
2. Ophthalmology. 2025 Jan;132(1):14-29. doi: 10.1016/j.ophtha.2024.07.014. Epub 2024 Jul 16. Oral Antioxidant and Lutein/Zeaxanthin Supplements Slow Geographic Atrophy Progression to the Fovea in Age-Related Macular Degeneration. Keenan TDL(1), Agrón E(2), Keane PA(3), Domalpally A(4), Chew EY(
3. JAMA Ophthalmol. 2022 Jul 1;140(7):692-698. doi: 10.1001/jamaophthalmol.2022.1640. Long-term Outcomes of Adding Lutein/Zeaxanthin and ω-3 Fatty Acids to the AREDS Supplements on Age-Related Macular Degeneration Progression: AREDS2 Report 28. Chew EY(1), Clemons TE(2), Agrón E(1), Domalpally A
4. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Evans JR(1), Lawrenson JG(2). Author information: (1)Centre for Public Health, Internationa
1. BMJ Open. 2026 Mar 26;16(3):e112364. doi: 10.1136/bmjopen-2025-112364. Effect of carotenoids supplementation on visual function in Chinese adults free of retinal disease: protocol for the CSV double-blind, randomised, placebo-controlled trial. Xu K(1), Tang X(1), Zhang Y(1), Tay JP(2), Zhang S(1), Qin Y(1), Wong W(1), He M(1)(3)(4)(5), Han X(6). Author information: (1)State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Sun Yat-sen University, Guangzhou, China. (2)Blackmores Institute, Sydney, New South Wales, Australia. (3)School of Optometry, The Hong Kong Polytechnic University, Hong Kong, People's Republic of China. (4)Research Centre for SHARP Vision (RCSV), The Hong Kong Polytechnic University, Hong Kong, People's Republic of China. (5)Centre for Eye and Vision Research (CEVR), Centre for Eye and Vision Research Limited, Hong Kong, People's Republic of China. (6)State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Sun Yat-sen University, Guangzhou, China lh.201205@aliyun.com. INTRODUCTION: The macula is a pigmented area located at the centre of the retina, responsible for central, high-resolution colour vision. Previous research has demonstrated that oral carotenoid supplementation can enhance contrast sensitivity (CS) in European populations. This study aims to investigate whether carotenoid supplementation can also improve visual function in the Chinese population. METHODS AND ANALYSIS: The Contrast Sensitivity Vision (CSV) trial is a double-blind, randomised controlled trial conducted at the Zhongshan Ophthalmic Center in Guangzhou, China. 220 eligible Chinese adults will be randomised in a 1:1 ratio to receive either oral supplementation of 10 mg lutein, 10 mg meso-zeaxanthin and 2 mg zeaxanthin in a formula-based oil suspension (administered as one soft gel capsule) or a placebo oil soft gel capsule daily for 1 year. Participants in both groups will undergo ophthalmological study procedures including best-corrected visual acuity (BCVA), contrast sensitivity, optical coherence tomography, fundus photography and skin carotenoid examinations at baseline and at 3-month, 6-month and 12-month follow-up visits. Blood tests and a Dietary Carotenoid Screening Questionnaire will be administered at baseline and at the 12-month follow-up. Subjective visual function questionnaire interviews will be administered at baseline and at the 3-month, 6-month and 12-month follow-ups. The primary outcome will assess change in CS at 6 cycles per degree (cpd) over the 1-year study intervention. Secondary outcomes will examine CS at 6 cpd at the 3-month and 6-month follow-up, CS at other cpd, BCVA, subjective visual function and skin carotenoid levels as measured at baseline, 3-month, 6-month and 12-month follow-ups. ETHICS AND DISSEMINATION: The CSV trial was approved by the Ethics Committee of the Zhongshan Ophthalmic Center, Guangzhou, China (No. KYPJ141-4). Participants will have the opportunity to ask questions about the trial, and written informed consent will be obtained from all participants prior to their involvement in the study. Results will be disseminated through peer-reviewed publication and conference presentations. TRIAL REGISTRATION NUMBER: NCT06098677. © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. DOI: 10.1136/bmjopen-2025-112364 PMCID: PMC13034290 PMID: 41887628 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: None declared.
2. 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.
3. Nutrients. 2025 Dec 19;18(1):4. doi: 10.3390/nu18010004. Nutritional Supplementation for Myopia Prevention and Control: A Systematic Review of Randomized Controlled Trials. Martinez-Perez C(1), Oliveira AP(2)(3). Author information: (1)Applied Physics Department (Optometry Area), Facultade de Óptica e Optometría, Universidade de Santiago de Compostela, 15705 Santiago de Compostela, Spain. (2)Instituto Superior de Educação e Ciências de Lisboa (ISEC Lisboa), Alameda das Linhas de Torres, 179, 1750-142 Lisboa, Portugal. (3)Centro de Investigação, Desenvolvimento e Inovação em Turismo (CiTUR)-Polo Estoril, Avenida Condes de Barcelona, n.° 808, 2769-510 Estoril, Portugal. BACKGROUND/OBJECTIVES: Nutritional supplementation has been proposed as a potential adjunct strategy in myopia prevention and control through antioxidative, anti-inflammatory, and extracellular matrix-regulating mechanisms. This systematic review aimed to evaluate randomized controlled trial (RCT) evidence on the effects of carotenoids, anthocyanins, polyunsaturated fatty acids, and combined nutraceutical formulations on refractive outcomes, axial length, macular pigment optical density (MPOD), visual function, and symptoms of visual fatigue. METHODS: The review was registered in PROSPERO (CRD420251149727) and conducted in accordance with PRISMA 2020 and AMSTAR-2 guidelines. PubMed, Web of Science, and Scopus were searched up to 5 August 2025. Eligible studies were RCTs involving individuals with myopia or at risk of myopia, comparing nutritional supplementation with placebo or active controls. Two reviewers independently screened studies, extracted data, and assessed risk of bias using the Cochrane RoB 2 tool. RESULTS: Nine RCTs were included. Carotenoids such as crocetin, lutein, zeaxanthin, and astaxanthin produced modest benefits, including improved MPOD, reduced visual fatigue, and-in one pediatric trial-slightly less axial elongation. Anthocyanin-rich extracts improved mesopic contrast sensitivity and subjective asthenopia. A combined carotenoid-polyphenol formulation enhanced accommodative facility. However, no consistent clinically meaningful reduction in myopia progression was observed. Trials were generally small, heterogeneous, and short in duration. CONCLUSIONS: Nutritional supplementation may improve visual function and retinal antioxidant status but lacks strong evidence for slowing myopia progression. Larger, long-term RCTs are needed before recommending supplementation for routine myopia management. DOI: 10.3390/nu18010004 PMCID: PMC12787848 PMID: 41515122 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest.
4. J Med Food. 2025 Aug;28(8):824-832. doi: 10.1089/jmf.2025.k.0060. Epub 2025 Jul 2. Enhanced Oral Bioavailability of Lutein and Zeaxanthin via a Self-Emulsifying Delivery System: A Randomized, Double-Blind Cross-Over Study. Choe BS(1), C A(2), Mk P(3), Kim J(4), Baek KS(4), Park YK(1). Author information: (1)Department of Medical Nutrition, Graduate School of East-West Medical Science, Kyung Hee University, Yongin-si, South Korea. (2)Medstar Speciality Hospital, Bengaluru, India. (3)Katra Phytochem Pvt., Ltd. Bengaluru, India. (4)Daehan Chemtech Co., Ltd, Gwacheon-si, South Korea. This study was conducted to evaluate and verify the improved bioavailability, as determined by the plasma concentrations of lutein and zeaxanthin, of the test supplement, XanMax® 2002 plus LuZeAbility™, as compared to the reference supplement, XanMax® 2002. For this purpose, this study was designed as a randomized, double-blind, two-group, two-period cross-over clinical trial research. A total of 24 male subjects participated in the clinical trial. They were randomized 1:1 into group 1 or 2 to consume two types of supplements in two separate periods. This study aimed to propose and demonstrate that the bioavailability and the plasma concentrations of lutein and zeaxanthin in the test supplement were significantly higher (110-132.8%) than in the reference supplement in all consecutive periods, such as 12 to 72 h after intake and at the time of maximum concentration. These results are expected to strengthen macular pigment optical density levels, ultimately providing a safe and effective intervention for comprehensively promoting eye health. Therefore, the findings of this study have significant pharmacokinetic implications and offer valid theoretical and practical insights for both academic research and the industrial development in the supplement market. DOI: 10.1089/jmf.2025.k.0060 PMID: 40601523 [Indexed for MEDLINE]
5. Cochrane Database Syst Rev. 2025 Apr 28;4(4):CD012178. doi: 10.1002/14651858.CD012178.pub2. Lutein and zeaxanthin for reducing morbidity and mortality in preterm infants. Choo YM(1), Yip KX(2), Fiander M(3), Ahmad Kamar A(1), Kamalden TA(4), Tan K(5)(6), Lai NM(7). Author information: (1)Department of Paediatrics, University of Malaya, Kuala Lumpur, Malaysia. (2)Department of Paediatrics, University of Malaya Medical Centre, Kuala Lumpur, Malaysia. (3)Cochrane Neonatal Group, Halifax, NS, Canada. (4)Department of Ophthalmology, University of Malaya, Kuala Lumpur, Malaysia. (5)Department of Paediatrics, Monash University, Melbourne, Australia. (6)Monash Newborn, Monash Children's Hospital, Melbourne, Australia. (7)School of Medicine, Taylor's University, Subang Jaya, Malaysia. Update of doi: 10.1002/14651858.CD012178. BACKGROUND: Lutein and zeaxanthin are nutrients with antioxidant properties found in the macula of the eye and brain tissue. They have been reported to play a role in reducing oxidative damage, especially in the eyes and possibly in other organ systems. Oxygen free radicals are one of the agents postulated to cause tissue damage in preterm infants, which leads to morbidities such as retinopathy of prematurity (ROP), intraventricular haemorrhage (IVH), and necrotising enterocolitis (NEC). Supplementation with lutein and zeaxanthin may reduce oxidative damage, hence reducing morbidity and mortality in preterm infants. OBJECTIVES: To assess the effectiveness of lutein and zeaxanthin supplementation in reducing morbidity and mortality in preterm infants. SEARCH METHODS: We conducted searches up to 17 December 2024 in CENTRAL, MEDLINE, Embase, and two trial registries. We also searched the reference lists of included studies, and related reviews and studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster-RCT, cross-over trials, and quasi-RCTs that compared lutein and zeaxanthin supplementation against placebo or no supplementation for preterm infants less than 37 completed weeks' postmenstrual age. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were the incidence of any stage of ROP, incidence of ROP stage 3 and above, incidence of visual impairment, and mortality assessed throughout the neonatal intensive care unit (NICU) stay. Secondary outcomes included the incidence of IVH, incidence of NEC, and any reported adverse effects. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included five studies (666 preterm infants) that compared lutein and zeaxanthin supplementation versus control (placebo or no supplementation). All five studies were conducted in high-income countries (Italy and the USA). We did not find any studies comparing lutein or zeaxanthin separately versus placebo or no supplementation. Most of the studies had a low risk of bias in most key domains, such as allocation concealment and blinding. The evidence suggests that lutein and zeaxanthin supplementation probably has little or no effect on ROP (any stage) when comparing infants who received lutein and zeaxanthin supplementation with those who did not (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.66 to 1.24; P = 0.53; I2 = 0%; 4 studies, 532 infants; moderate-certainty evidence). Lutein and zeaxanthin supplementation probably reduces the incidence of ROP stage 3 and above (RR 0.49, 95% CI 0.29 to 0.81; P = 0.005; I2 = 0%; 4 studies, 532 infants; moderate-certainty evidence). No studies assessed the incidence of visual impairment. Lutein and zeaxanthin supplementation may have little or no effect on mortality assessed throughout the NICU stay (RR 0.95, 95% CI 0.42 to 2.17; P = 0.91; I2 = 0%; 4 studies, 470 infants; low-certainty evidence), incidence of IVH (all grades) (RR 0.87, 95% CI 0.44 to 1.75; P = 0.70; I2 = 0%; 4 studies, 483 infants; low-certainty evidence), and incidence of NEC: Bell's stage II or greater (RR 0.87, 95% CI 0.43 to 1.76; P = 0.71; I2 = 0%; 5 studies, 666 infants; low-certainty evidence). No adverse effects were reported in either group. AUTHORS' CONCLUSIONS: While supplementation with lutein and zeaxanthin from day one of life in preterm infants until discharge probably reduces the incidence of ROP stage 3 and above, it may have little or no effect on the incidence of ROP at any stage, IVH or NEC, or mortality assessed throughout the NICU stay. However, the pooled estimates for these outcomes may change with further rigorously conducted trials. There were no adverse effects reported. Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DOI: 10.1002/14651858.CD012178.pub2 PMCID: PMC12035999 PMID: 40292760 [Indexed for MEDLINE] Conflict of interest statement: Yao Mun Choo has declared that he has no conflict of interest. Azanna Ahmad Kamar has declared that she is affiliated with the following organisations, which have no declared opinion or position on the topic: (1) Federation of Asia Oceania Perinatal Societies (FAOPS) ‐ Committee Member; (2) Perinatal Society of Malaysia ‐ Council Member. She currently holds a grant award for a separate study on a premature infant's diet. Title of project: Effect of maternal dietary practice on breast milk composition and preterm infant outcomes (PREM‐MOM‐DIET PROJECT). Grant awarded by: University Malaya Specialist Centre Cares Research Grant. She holds an unpaid government committee position responsible for monitoring and ensuring the compliance of organisations with the code of ethics in the marketing of infant food and related food products. She has given lectures organised by AstraZeneca (invited speaker on respiratory syncytial virus (RSV), International Education Programme) that are not related to the subject of the Cochrane review. Her institution received funding from AstraZeneca for these lectures. Tengku Ain Kamalden has declared that she has no conflict of interest. Kenneth Tan has declared that he has no conflict of interest. Michelle Fiander works with Cochrane Neonatal as a Managing Editor and Information Specialist, but was not involved in the editorial acceptance of this manuscript. Nai Ming Lai has been an Associate Editor for Cochrane Neonatal. However, his participation in the editorial group has not impacted this review. He is also a Sign‐off Editor for the Cochrane Central Editorial Service (however he was not involved in the editing of the current work) and an Editor for Cochrane Clinical Answers. Ke Xin Yip has declared that she has no conflict of interest.
6. Cureus. 2025 Feb 22;17(2):e79481. doi: 10.7759/cureus.79481. eCollection 2025 Feb. Beneficial Effects of a Lutein-Zeaxanthin Complex on Macular Pigment Optical Density Levels of Healthy Individuals With Prolonged Screen Time. Bharadwaj VG(1), Mb T(2), Hv A(3), Ca A(1), R S(1), Cp P(1), Mv J(1), Eranimose B(1), Reddy PA(1). Author information: (1)Research and Development, Olive Lifesciences Pvt. Ltd., Bangalore, IND. (2)Ophthalmology, Narayana Nethralaya, Bangalore, IND. (3)Clinical Research, SCORES, Bangalore, IND. Introduction Macular pigment (MP), consisting of lutein (L) and zeaxanthin (Z), is believed to provide retinal protection against photo-oxidative damage. The objective of the study was to evaluate the effect of lutein and zeaxanthin complex 5:1 (extracted from marigold flowers) supplementation on macular pigment optical density (MPOD), contrast sensitivity, and quality of sleep in healthy subjects who exposed themselves to an electronic gadget screen for a minimum of 8 hours every day. This study also aimed to assess the long-term safety of the supplement by administering it for 8 months in one of the groups. The study also assessed the retention effects of lutein and zeaxanthin on MPOD after discontinuation of supplementation. Methods The study was registered with the Clinical Trial Registry of India (CTRI/2022/12/048392). Subjects were screened as per the defined inclusion and exclusion criteria. Subjects aged 18-55 years with a screen time of at least 8 hours daily and MPOD values below 0.8 were recruited. The study, conducted at Narayana Nethralaya Super Specialty Eye Hospital, Bangalore, spanned from December 2022 to May 2024. This was a randomized, placebo-controlled, crossover study. Of the 96 volunteers screened for this study, 71 were recruited, and 60 completed the study. Subjects were divided into 3 groups, viz. A, B, and C. Group A received lutein 10mg and zeaxanthin 2mg twice daily for the first four months, had a wash-off period of 15 days, and continued with the same supplementation for the remaining four months. Group B received lutein 10mg and zeaxanthin 2mg twice daily for the first four months, had a wash-off period of 15 days, and then switched over to a placebo for the next four months. Group C received a Placebo for the first 4 months, had a wash-off period of 15 days, and then switched over to lutein 10mg and zeaxanthin 2mg for the next four months. All the subjects were given either, lutein and zeaxanthin complex-5:1 or placebo capsules as per the randomization chart prepared computationally. Subjects were analyzed for their MPOD values, contrast sensitivity scores, and quality of sleep. Intraocular pressure, retinal thickness, renal function tests, and liver function tests were conducted during visits to ensure clinical safety. Results After supplementation with the lutein-zeaxanthin complex-5:1, the average MPOD (at 1ᴏ eccentricity) increased significantly. At the first visit, the mean MPOD for Groups A, B, and C were 0.3, 0.22, and 0.29 (right eye) and 0.31, 0.27, and 0.27 (left eye), respectively. At the second visit, these values were 0.61, 0.66, and 0.21 (right eye) and 0.54, 0.53, and 0.2 (left eye). By the third visit, the mean MPOD values were 0.7, 0.65, and 0.38 (right eye) and 0.66, 0.53, and 0.36 (left eye). Supplementation significantly improved MPOD, contrast sensitivity, and the quality of sleep compared to placebo. Conclusions The supplementation with lutein and zeaxanthin resulted in higher MPOD values as compared to that of the placebo. This intervention also led to improvement in contrast sensitivity and quality of sleep. Lutein and zeaxanthin complex-5:1 may be a promising remedial measure for increasing the MPOD of people exposed to prolonged screen time. Copyright © 2025, Bharadwaj et al. DOI: 10.7759/cureus.79481 PMCID: PMC11933726 PMID: 40135032 Conflict of interest statement: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Narayana Nethralaya Ethics Committee issued approval C/2022/12/13. The Institutional Ethics Committee of Narayana Nethralaya reviewed and discussed the documents submitted by you related to the conduct of the above-mentioned study at the virtual meeting held on 13 Dec 2022. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: Study was conducted at Narayana Nethralaya Hospital , Bangalore. Financial relationships: Vadiraj G Bharadwaj, Anzar CA, Sundaram R, Prasad CP, Joseph MV, Bineesh Eranimose, Prasanna A Reddy declare(s) employment from Olive Lifesciences Pvt. Ltd. Intellectual property info: The composition used in this clinical trial is about to be patented. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
7. Nutrients. 2024 Dec 18;16(24):4366. doi: 10.3390/nu16244366. Effect of Dietary Supplementation with Lutein, Zeaxanthin, and Elderberries on Dry Eye Disease (DED) and Immunity: A Randomized Controlled Trial. Goh KM(1)(2), Tan ESS(3), Lim CSY(4), Tan PY(5), Biswas S(6), Lew LA(2)(7), Tan CK(3). Author information: (1)New Product Development Department, Ecolite Biotech Manufacturing, Yong Peng 83400, Malaysia. (2)Product Development Department, Xmegami Manufacturing, Puchong 47170, Malaysia. (3)Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur 56000, Malaysia. (4)Faculty of Applied Sciences, UCSI University, Kuala Lumpur 56000, Malaysia. (5)Faculty of Environment, University of Leeds, Leeds LS2 9JT, UK. (6)School of Optometry, College of Health and Life Sciences, Aston University, Birmingham B4 7ET, UK. (7)Faculty of Food Science and Technology, Universiti Putra Malaysia, Serdang 43400, Malaysia. BACKGROUND/OBJECTIVES: Dry eye disease (DED) significantly impairs quality of life, affecting physical, social, and psychological well-being, as well as reducing workplace productivity. While lutein and zeaxanthin supplements have been shown to improve ocular health, existing research often overlooks the efficacy of lower dosages and shorter durations of supplementation. This study investigated the effects of combined supplementation with lutein, zeaxanthin, and elderberries in 110 voluntary participants through a randomized controlled trial. METHODS: Participants took 6 mg of lutein and 1 mg of zeaxanthin, along with 100 mg elderberry extract once daily for a duration of 20 days. Ocular health was assessed using the Ocular Surface Disease Index (OSDI), while immune status was evaluated with the Immune Status Questionnaire (ISQ). RESULTS: Results showed that combined supplementation significantly (p < 0.05) reduced the OSDI scores in the intervention group from 38.15 ± 11.14 to 18.26 ± 5.57, reflecting a 52.2% reduction. A similar trend was observed with the Visual Analog Scale (VAS), indicating significant (p < 0.05) improvement from 5.31 ± 1.62 to 6.73 ± 1.74, equivalent to a 26.7% improvement. Although the intervention group showed a 15.9% improvement in ISQ scores by the study's end, this was not significantly different from the placebo group, suggesting that higher dosages or longer durations may be needed to observe a meaningful effect. Additionally, findings from the Food Frequency Questionnaire revealed that the average dietary intake of lutein and zeaxanthin among participants was only 663.49 µg, equating to just 5.5% of the suggested optimal daily intake. This low consumption is concerning, as it is inversely correlated with the risk of ocular diseases. CONCLUSIONS: Collectively, these findings support the use of combined supplementation as an adjuvant approach to improving ocular health. DOI: 10.3390/nu16244366 PMCID: PMC11679324 PMID: 39770987 [Indexed for MEDLINE] Conflict of interest statement: Author Kok Ming Goh was employed by the company Ecolite Biotech Manufacturing. Authors Kok Ming Goh and Li Ann Lew were employed by the company Xmegami Manufacturing. 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.
8. Nutrients. 2024 Nov 28;16(23):4124. doi: 10.3390/nu16234124. Nutritional Genomics: Implications for Age-Related Macular Degeneration. Figueiredo I(1), Farinha C(1)(2)(3)(4), Barreto P(2)(4), Coimbra R(2), Pereira P(1)(3), Marques JP(1)(2)(3)(4), Pires I(1)(2)(3)(4), Cachulo ML(1)(2)(3)(4), Silva R(1)(2)(3)(4). Author information: (1)Ophthalmology Department, Unidade Local de Saúde Coimbra, 3004-561 Coimbra, Portugal. (2)AIBILI-Association for Innovation and Biomedical Research on Light and Image, 3000-548 Coimbra, Portugal. (3)Clinical Academic Center of Coimbra (CACC), 3000-548 Coimbra, Portugal. (4)Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine (iCBR-FMUC), University of Coimbra, 3004-531 Coimbra, Portugal. Background: Age-related macular degeneration (AMD) is a leading cause of vision loss in older individuals, driven by a multifactorial etiology involving genetic, environmental, and dietary factors. Nutritional genomics, which studies gene-nutrient interactions, has emerged as a promising field for AMD prevention and management. Genetic predispositions, such as variants in CFH, C3, C2/CFB, APOE, and oxidative stress pathways, significantly affect the risk and progression of AMD. Methods: This narrative review synthesizes findings from randomized controlled trials and recent advances in nutritional genomics research. It examines the interplay between genetic predispositions and dietary interventions, exploring how personalized nutritional strategies can optimize AMD management. Results and Discussion: The AREDS and AREDS2 trials demonstrated that supplements, including vitamins C, E, zinc, copper, lutein, and zeaxanthin, can reduce the progression to advanced AMD. Nutritional interventions tailored to genetic profiles show promise: CFH risk alleles may enhance zinc supplementation's anti-inflammatory effects, while APOE variants influence the response to omega-3 fatty acids. Adjusting carotenoid intake, such as lutein and zeaxanthin, based on genetic susceptibility exemplifies emerging precision nutritional approaches. Ongoing research seeks to integrate nutrigenomic testing into clinical settings, enabling clinicians to tailor interventions to individual genetic profiles. Conclusions: Further studies are needed to assess the long-term effects of personalized interventions, investigate additional genetic variants, and develop tools for clinical implementation of nutrigenomics. Advancing these strategies holds the potential to improve patient outcomes, optimize AMD management, and pave the way for precision nutrition in ophthalmology. DOI: 10.3390/nu16234124 PMCID: PMC11643977 PMID: 39683519 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest.
9. Nutrients. 2024 Nov 20;16(22):3971. doi: 10.3390/nu16223971. Beneficial Effects of Micronutrient Supplementation in Restoring the Altered Microbiota and Gut-Retina Axis in Patients with Neovascular Age-Related Macular Degeneration-A Randomized Clinical Trial. Baldi S(1), Pagliai G(1), Di Gloria L(2), Pallecchi M(3), Barca F(4), Pieri B(4), Bartolucci G(3), Ramazzotti M(2), Amedei A(1)(5), Palendri G(4), Sofi F(1)(6). Author information: (1)Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy. (2)Department of Biomedical, Experimental and Clinical Sciences "Mario Serio", University of Florence, 50134 Florence, Italy. (3)Department of Neuroscience, Psychology, Drug Research and Child Health NEUROFARBA, University of Florence, 50139 Florence, Italy. (4)Complex Operative Unit of Ophthalmology, Palagi Hospital, USL Toscana Centro, 50122 Florence, Italy. (5)Network of Immunity in Infection, Malignancy and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Florence, Italy. (6)Unit of Clinical Nutrition, Careggi University Hospital, 50134 Florence, Italy. Background/Objectives: Age-related macular degeneration (AMD) is a leading cause of visual impairment in the elderly and is characterized by a multifactorial etiology. Emerging evidence points to the potential involvement of the gut-retina axis in AMD pathogenesis, prompting exploration into novel therapeutic strategies. This study aims to investigate the effects of some micronutrients (such as lutein and zeaxanthin) and saffron (as a supplement)-known for their anti-inflammatory properties-on ophthalmological and microbial parameters in neovascular AMD (nAMD) patients. Methods: Thirty naive nAMD patients were randomized to receive daily micronutrient supplementation alongside anti-VEGF (vascular endothelial growth factor) therapy, or anti-VEGF treatment alone, over a 6-month period, with comparisons made to a healthy control (HC) group (N = 15). Ophthalmological assessments, biochemical measurements, and stool samples were obtained before and after treatment. Gut microbiota (GM) characterization was performed using 16S rRNA sequencing, while short-chain fatty acids (SCFAs), medium-chain fatty acids (MCFAs), and long-chain fatty acids (LCFAs) were analyzed with a gas chromatography-mass spectrometry protocol. Results: Compared to HC, nAMD patients exhibited reduced GM alpha diversity, altered taxonomic composition, and decreased total SCFA levels, in addition to elevated levels of proinflammatory octanoic and nonanoic acids. Micronutrient supplementation was associated with improved visual acuity relative to the group treated with anti-VEGF alone, along with a decrease in the total amount of MCFAs, which are metabolites known to have adverse ocular effects. Conclusions: In conclusion, despite certain limitations-such as the limited sample size and the low taxonomic resolution of 16S rRNA sequencing-this study highlights compositional and functional imbalances in the GM of nAMD patients and demonstrates that micronutrient supplementation may help restore the gut-retina axis. These findings suggest the therapeutic potential of micronutrients in enhancing ocular outcomes for nAMD patients, underscoring the complex interaction between GM and ocular health. DOI: 10.3390/nu16223971 PMCID: PMC11597754 PMID: 39599758 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest.
10. Front Ophthalmol (Lausanne). 2024 Apr 24;4:1362113. doi: 10.3389/fopht.2024.1362113. eCollection 2024. A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial. Gioia N(1), Gerson J(2), Ryan R(3), Barbour K(3), Poteet J(4), Jennings B(5), Sharp M(5), Lowery R(5), Wilson J(5), Morde A(6), Rai D(6), Padigaru M(6), Periman LM(7). Author information: (1)Integrative Vision Corp, Shrewsbury, NJ, United States. (2)Grin Eye Care, Olathe, KS, United States. (3)Medical Affairs Bausch + Lomb, Bridgewater, NJ, United States. (4)MyEyeDr, Acworth, GA, United States. (5)Applied Science and Performance Institute, Tampa, FL, United States. (6)OmniActive Health Technologies, Mumbai, India. (7)Dry Eye Master, Seattle, WA, United States. INTRODUCTION: Dry eye disease (DED) is multifactorial and characterized by a loss of tear film homeostasis that causes a cycle of tear film instability, tear hyperosmolarity, and inflammation. While artificial tears are the traditional mainstay of treatment, addressing the underlying pathophysiology could relieve symptoms and prevent progression. Increasing evidence indicates a role for oral nutritional supplementation in multiple ophthalmic diseases, including DED. Lutein, zeaxanthin, curcumin, and vitamin D3 have demonstrated protective and anti-inflammatory properties in ocular models. This prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of a proprietary blend of lutein, zeaxanthin isomers, curcumin, and vitamin D3 (LCD) as a daily supplement in adult participants with DED. METHODS: Participants were randomized to receive one LCD supplement capsule (lutein 20 mg, zeaxanthin isomers 4 mg, curcumin 200 mg curcuminoids, and vitamin D3 600 IU) or placebo per day for 8 weeks (LCD, n=77; placebo, n=78). Primary outcomes were changes in tear volume (Schirmer's test) and ocular symptoms (Ocular Surface Disease Index [OSDI]). RESULTS: The study met its primary endpoints: the LCD group demonstrated significantly better Schirmer's test scores and improvement in overall OSDI score, versus placebo, at Day 56 (p<0.001 for both). Scores for total OSDI, and symptoms and vision domains, significantly improved by Day 14 for LCD versus placebo, (p<0.05 for all) and were maintained to Day 56 (p<0.001). In addition, the LCD group demonstrated significantly improved tear film break-up time (TBUT) and tear film osmolarity, versus placebo, by Day 56 (p<0.001), along with significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation (matrix metalloproteinase-9; p<0.001 for each eye). Total Standard Patient Evaluation of Eye Dryness (SPEED) score, and scores for the frequency and severity domains, were significantly improved by Day 14 for LCD versus placebo (p<0.05 for all) and maintained to Day 56 (p<0.001). There was no difference between groups for artificial tear usage. The supplement was well-tolerated. DISCUSSION: Once-daily LCD supplementation significantly improved tear production, stability and quality, reduced ocular surface damage and inflammation, and improved participants' symptoms. LCD supplementation could offer a useful adjunct to artificial tears for patients with DED (NCT05481450). Copyright © 2024 Gioia, Gerson, Ryan, Barbour, Poteet, Jennings, Sharp, Lowery, Wilson, Morde, Rai, Padigaru and Periman. DOI: 10.3389/fopht.2024.1362113 PMCID: PMC11182317 PMID: 38984118 Conflict of interest statement: RR and KB are employees of Bausch + Lomb Incorporated. AM, DR and MP and employees of OmniActive Health Technologies. NG, JG, JP and LP are advisory board committee members for Bausch + Lomb. 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.
11. Nutr Metab Cardiovasc Dis. 2024 Aug;34(8):1976-1983. doi: 10.1016/j.numecd.2024.05.009. Epub 2024 May 14. Lutein, zeaxanthin, and meso-zeaxanthin supplementation attenuates inflammatory cytokines and markers of oxidative cardiovascular processes in humans. Stringham NT(1), Green M(2), Roche W(2), Prado-Cabrero A(2), Mulcahy R(2), Nolan J(2). Author information: (1)Nutrition Research Centre Ireland (NRCI), Southeast Technical University, Waterford, Ireland; Northern Arizona University, Flagstaff, AZ, USA. Electronic address: ntstringham@gmail.com. (2)Nutrition Research Centre Ireland (NRCI), Southeast Technical University, Waterford, Ireland. BACKGROUND AND AIMS: Systemic inflammation and oxidation are primary contributors to the development of atherosclerosis. Oxidation of low-density lipoprotein (LDL) particles within the vascular endothelium has been hypothesized to be an initial step in the formation of atherosclerotic plaques, with inflammatory cytokines serving as the signaling mechanism for concomitant macrophage activation. Supplementation with the antioxidative macular xanthophylls (lutein [L], zeaxanthin [Z], and meso-zeaxanthin [MZ]) has been shown to aid in the reduction of inflammatory physiologic responses; therefore, we hypothesized that in our study population, supplementation with these xanthophylls would facilitate a systemic reduction in markers of inflammation and cardiovascular lipid oxidation. METHODS AND RESULTS: In this double-blind placebo-controlled supplementation study, participants were randomly allocated to receive the active intervention containing L (10 mg) + MZ (10 mg) + Z (2 mg) or placebo (containing sunflower oil). Serum concentrations of carotenoids (assessed by HPLC), inflammatory cytokines (IL-6, IL-1β, TNF-α) and oxidized LDL (OxLDL; by solid-phase sandwich ELISA) were measured at baseline and at 6-months. Results showed that over the supplementation period, compared to placebo, the active group demonstrated statistically significant increases in serum concentrations of L, Z, & MZ (p < 0.05), reductions in inflammatory cytokines IL-1β (p < 0.001) and TNF-α (p = 0.003), as well as a corresponding reduction in serum OxLDL (p = 0.009). CONCLUSIONS: Our data show that L, Z, & MZ supplementation results in decreased serum IL-1β, TNF-α, and OxLDL. This suggests that these carotenoids are acting systemically to attenuate oxidative lipid products and inflammation, thus reducing their contribution to atherosclerotic plaque formation. Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved. DOI: 10.1016/j.numecd.2024.05.009 PMID: 38890092 [Indexed for MEDLINE] Conflict of interest statement: Declaration of competing interest N.S. has performed consultancy work for Industrial Organica. M.G. has performed consultancy work for Industrial Organica and MacuHealth LLC. A.P.-C. is co-founder of Supplement Certified Ltd. W.R. declares no conflict of interest. R.M. declares no conflict of interest. J.M.N. does consultancy work as a director of NOW Science Consultancy Ltd. for companies with an interest in food supplements and also is a director of Supplement Certified Ltd.
12. Nutrients. 2024 May 8;16(10):1415. doi: 10.3390/nu16101415. Bioavailability of Lutein from Marigold Flowers (Free vs. Ester Forms): A Randomised Cross-Over Study to Assess Serum Response and Visual Contrast Threshold in Adults. Olmedilla-Alonso B(1), Granado-Lorencio F(2), Castro-Feito J(3), Herrero-Barbudo C(2), Blanco-Navarro I(2), Estévez-Santiago R(4). Author information: (1)Instituto de Ciencia y Tecnología de Alimentos y Nutrición (ICTAN-CSIC), c/José Antonio Novais, 6, 28040 Madrid, Spain. (2)Hospital Universitario Puerta de Hierro-Majadahonda, c/Maestro Rodrigo, 2, 28222 Majadahonda, Spain. (3)Optometric Center Zires, c/Juan de Austria, 16, 28016 Madrid, Spain. (4)Facultad de Ciencias de la Salud, Universidad Francisco de Vitoria, Ctra. Pozuelo-Majadahonda Km 1800, 28223 Pozuelo de Alarcón, Spain. Lutein (Lut) and zeaxanthin (Zeax) are found in the blood and are deposited in the retina (macular pigment). Both are found in the diet in free form and esterified with fatty acids. A high intake and/or status is associated with a lower risk of chronic diseases, especially eye diseases. There is a large global demand for Lut in the dietary supplement market, with marigold flowers being the main source, mainly as lutein esters. As the bioavailability of Lut from free or ester forms is controversial, our aim was to assess the bioavailability of Lut (free vs. ester) and visual contrast threshold (CT). Twenty-four healthy subjects (twelve women, twelve men), aged 20-35 and 50-65 years, were enrolled in a cross-sectional study to consume 6 mg lutein/day from marigold extract (free vs. ester) for two months. Blood samples were taken at baseline and after 15, 40, and 60 days in each period. Serum Lut and Zeax were analysed using HPLC, and dietary intake was determined with a 7-day food record at the beginning of each period. CT, with and without glare, was at 0 and 60 days at three levels of visual angle. Lut + Zeax intake at baseline was 1.9 mg/day, and serum lutein was 0.36 µmol/L. Serum lutein increased 2.4-fold on day 15 (up to 0.81 and 0.90 µmol/L with free and ester lutein, respectively) and was maintained until the end of the study. Serum Zeax increased 1.7-fold. There were no differences in serum Lut responses to free or ester lutein at any time point. CT responses to lutein supplementation (free vs. ester) were not different at any time point. CT correlated with Lut under glare conditions, and better correlations were obtained at low frequencies in the whole group due to the older group. The highest correlations occurred between CT at high frequency and with glare with serum Lut and Lut + Zeax. Only in the older group were inverse correlations found at baseline at a high frequency with L + Z and with Lut/cholesterol and at a low frequency with Lut/cholesterol. In conclusion, daily supplementation with Lut for 15 days significantly increases serum Lut in normolipemic adults to levels associated with a reduced risk of age-related eye disease regardless of the chemical form of lutein supplied. Longer supplementation, up to two months, does not significantly alter the concentration achieved but may contribute to an increase in macular pigment (a long-term marker of lutein status) and thus improve the effect on visual outcomes. DOI: 10.3390/nu16101415 PMCID: PMC11123982 PMID: 38794653 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest.
13. Adv Nutr. 2024 May;15(5):100216. doi: 10.1016/j.advnut.2024.100216. Epub 2024 Apr 4. Effect of Antioxidant Supplementation on Macular Pigment Optical Density and Visual Functions: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Hu W(1), Seah V(1), Huang V(1), Kim JE(2). Author information: (1)Department of Food Science and Technology, National University of Singapore, Singapore. (2)Department of Food Science and Technology, National University of Singapore, Singapore. Electronic address: fstkje@nus.edu.sg. Antioxidants are bioactive molecules that function to scavenge free radicals and balance oxidative stress. Although all antioxidants can act as reactive oxygen species scavengers, their efficacy on eye health may vary. Moreover, the comparative effectiveness and potential additive effect between groups of antioxidants, hitherto, have not been systematically studied. A systematic review and network meta-analysis were conducted to investigate the comparative or additive effect of dietary antioxidant supplements on eye health. Four databases (PubMed, Embase, CINAHL, and Cochrane) were searched, and relevant randomized controlled trials were identified. Out of 60 articles selected for systematic review, 38 were included in the network meta-analysis, categorized into 8 distinct antioxidant-supplemented groups and placebo. All groups significantly increased macular pigment optical density and contrast sensitivity at low spatial frequency, whereas only the antioxidant mixture + lutein (L) + fatty acid combination exhibited significant improvements in visual acuity (hazard ratio = -0.15; 95% confidence interval: -0.28, -0.02) and L + zeaxanthin combination for photostress recovery time (hazard ratio = -5.75; 95% confidence interval: -8.80, -1.70). Especially, the L + zeaxanthin + fatty acid combination was ranked best for macular pigment optical density (surface under the cumulative ranking: 99.3%) and second best for contrast sensitivity at low spatial frequency (67.7%). However, these findings should be interpreted with caution due to low quality of evidence, primarily influenced by indirectness and potential publication bias. Overall, antioxidant supplementation was estimated to improve eye health parameters, whereas different combinations of antioxidants may also have varying effects on improving visual health from multiple perspectives. This study was registered at PROSPERO as CRD42022369250. Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved. DOI: 10.1016/j.advnut.2024.100216 PMCID: PMC11052915 PMID: 38582248 [Indexed for MEDLINE]
14. Adv Ther. 2024 Apr;41(4):1496-1511. doi: 10.1007/s12325-024-02785-1. Epub 2024 Feb 16. Lutein and Zeaxanthin Supplementation Improves Dynamic Visual and Cognitive Performance in Children: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study. Parekh R(1), Hammond BR Jr(2), Chandradhara D(3). Author information: (1)Sanjeevani Netralaya, Infantry Road (Bhagwan Mahaweer Road), Opp. The Hindu, Near Income Tax Office, Bengaluru, 560001, India. (2)Department of Psychology, UGA Psychology Department, University of Georgia, 125 Baldwin Street, Athens, GA, 30602, USA. (3)Bioagile Therapeutics Pvt. Ltd., #2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bengaluru, 560094, India. divya@bioagiletherapeutics.com. INTRODUCTION: Supplementation with dietary neuro-pigments lutein (L) and zeaxanthin (Z) has been shown to improve many aspects of visual and cognitive function in adults. In this study, we tested whether a similar intervention could improve such outcomes in preadolescent children. METHODS: Sixty children (age range 5-12 years) were randomized in a 2:1 ratio in this double-blind, placebo-controlled clinical trial. Subjects were supplemented with gummies containing either a combination of 10 mg lutein and 2 mg zeaxanthin (LZ) or placebo for 180 days. Macular pigment optical density (MPOD) was the primary endpoint. The secondary endpoints included serum levels of L and Z, and brain-derived neurotrophic factor (BDNF), critical flicker fusion (CFF), eye strain and fatigue using visual analogue scales (VAS), Children's Sleep Habits Questionnaire-Abbreviated (CSHQ-A), and Creyos Health cognitive domains like attention, focus/concentration, episodic memory and learning, visuospatial working memory, and visuospatial processing speed. Safety was assessed throughout the study on the basis of physical examination, vital signs, clinical laboratory tests, and monitoring of adverse events. RESULTS: The LZ group showed significant increases in MPOD at all visits post-supplementation, with significant increases as early as day 42 compared to placebo. The LZ group showed significant increases in serum lutein levels, reduced eye strain and fatigue, and improved cognitive performance (focus, episodic memory and learning, visuospatial working memory) at days 90 and 180 compared to placebo. Further, the LZ group showed significant increases in processing speed (CFF), attention, visuospatial processing, and serum Z and BDNF levels on day 180 compared to placebo. No safety concerns were observed. CONCLUSIONS: Supplementing LZ resulted in increased MPOD levels, along with increased serum levels of L, Z, and BDNF. These changes were associated with improved visual and cognitive performances and reduction in eye strain and eye fatigue in the children receiving LZ gummies. The investigational product was safe and well tolerated. TRIAL REGISTRATION: http://ctri.nic.in/ Identifier CTRI/2022/05/042364. © 2024. The Author(s). DOI: 10.1007/s12325-024-02785-1 PMCID: PMC10960892 PMID: 38363462 [Indexed for MEDLINE] Conflict of interest statement: Rajesh Parekh is affiliated to the clinical study site, Sanjeevani Netralaya, where the study was conducted. Billy R. Hammond Jr is a professor at the University of Georgia, Athens and supported as a consultant for the sponsor in study and manuscript development. Divya Chandradhara is an employee of Bioagile Therapeutics Pvt. Ltd., the Contract Research Organization contracted to conduct the presented study.
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