아쉬와간다 (근력)

Ashwagandha Root Extract Stabilises Physiological Stress Responses in Male and Female Team Sports Athletes During Pre-Season Training.

1. Nutrients. 2026 Jan 12;18(2):230. doi: 10.3390/nu18020230. Ashwagandha Root Extract Stabilises Physiological Stress Responses in Male and Female Team Sports Athletes During Pre-Season Training. Coope OC(1), Otaegui E(2), Suárez M(2), Levington A(3), Abad-Sangrà M(4), Lloyd B(5), Spurr TJ(6),

Effects of Root Extract of Ashwagandha (Withania somnifera) on Perception of Recovery and Muscle Strength in Female Athletes.

2. Eur J Sport Sci. 2025 Mar;25(3):e12265. doi: 10.1002/ejsc.12265. Effects of Root Extract of Ashwagandha (Withania somnifera) on Perception of Recovery and Muscle Strength in Female Athletes. Coope OC(1), Reales Salguero A(2), Spurr T(3), Páez Calvente A(2), Domenech Farre A(2), Jordán Fisas E

Effects of Ashwagandha ( Withania somnifera) standardized root extract on physical endurance and VO (2max) in healthy adults performing resistance training: An eight-week, prospective, randomized, double-blind, placebo-controlled study.

3. F1000Res. 2024 Apr 8;12:335. doi: 10.12688/f1000research.130932.2. eCollection 2023. Effects of Ashwagandha ( Withania somnifera) standardized root extract on physical endurance and VO (2max) in healthy adults performing resistance training: An eight-week, prospective, randomized, double-blin

Clinical evidence for the adaptogenic effects of Withania somnifera and Rhodiola rosea - A systematic review with molecular interpretation of psychometric outcomes.

4. Ann Agric Environ Med. 2026 Mar 25;33(1):3-11. doi: 10.26444/aaem/213417. Epub 2025 Dec 9. Clinical evidence for the adaptogenic effects of Withania somnifera and Rhodiola rosea - A systematic review with molecular interpretation of psychometric outcomes. Łuszczak J(1), Kocki J(2). Author i

Withania somnifera (Indian ginseng) in diabetes mellitus: A systematic review and meta-analysis of scientific evidence from experimental research to clinical application.

5. Phytother Res. 2020 May;34(5):1041-1059. doi: 10.1002/ptr.6589. Epub 2020 Jan 23. Withania somnifera (Indian ginseng) in diabetes mellitus: A systematic review and meta-analysis of scientific evidence from experimental research to clinical application. Durg S(1), Bavage S(1), Shivaram SB(2).

Withania somnifera (Indian ginseng) in male infertility: An evidence-based systematic review and meta-analysis.

6. Phytomedicine. 2018 Nov 15;50:247-256. doi: 10.1016/j.phymed.2017.11.011. Epub 2017 Nov 29. Withania somnifera (Indian ginseng) in male infertility: An evidence-based systematic review and meta-analysis. Durg S(1), Shivaram SB(2), Bavage S(3). Author information: (1)Independent Researcher, B

Effectiveness of Ayurvedic Nutritional Supplements and Yoga Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS Study): Study Protocol for an Open-Label Randomized Controlled Trial.

1. JMIR Res Protoc. 2026 Apr 8;15:e81567. doi: 10.2196/81567. Effectiveness of Ayurvedic Nutritional Supplements and Yoga Protocol in Reducing the Incidence and Severity of Acute Mountain Sickness (AYAMS Study): Study Protocol for an Open-Label Randomized Controlled Trial. Rai AK(1), Jameela S(2), Yadav AK(3), Joshi RK(3), Mundada P(2), Ahmad A(2), Mahajon B(4), Sharma BS(2), Khanduri S(2), Yadav B(2), Tripathi A(2), Rana RK(2), Chandrasekhararao B(2), Srikanth N(2), Rao R(5), Acharya R(2). Author information: (1)Ayurvedic and Unani Tibbia College and Hospital, New Delhi, India. (2)Central Council for Research in Ayurvedic Sciences, New Delhi, India. (3)Office of the DGAFMS, Fifth Floor, Block A, Defence Officer Complex, Africa Avenue, New Delhi, 110023, India, 91 9868815430. (4)All India Institute of Ayurveda, New Delhi, India. (5)Central Council for Research in Yoga and Naturopathy, New Delhi, India. BACKGROUND: Acute mountain sickness (AMS) poses a unique and formidable challenge to healthy personnel at high altitudes. OBJECTIVE: This randomized controlled trial (RCT) protocol aimed to assess the effectiveness of Ayurvedic nutritional supplements in conjunction with a yoga protocol in reducing the incidence and severity of AMS among healthy personnel stationed in the challenging high-altitude landscapes of the western Himalayas. METHODS: The proposed open-label, parallel-group RCT was conducted in apparently healthy individuals of any gender aged 18-50 years. The study was conducted at two distinct high-altitude stages within the western Himalayan region: stage I, situated at an elevation ranging from 9000 to 12,000 feet and stage II, spanning 12,000 to 15,000 feet. A total of 1660 participants (n=830 per stage) underwent random assignment in a 1:1 ratio to receive either the existing acclimatization schedule (AS) for high altitude (control group) or the Ayush intervention (Ayush group) in addition to the AS. The participants in the Ayush group received Ayurvedic nutritional supplements, including the Ayur-nutri kit (Ayush poshak yoga, 25 g, and Ayush cardiac care tea, 125 mL), twice daily, along with a yoga protocol (60 min daily) for 120 days. The primary outcome was the incidence of AMS, assessed using the 2018 Lake Louise Scoring System, and the proportion of participants with a Lake Louise Scoring System score of 6 or higher during the first 7 days from baseline. The secondary outcome measures included the proportion of participants with thromboembolic events; changes in coagulation and hemostasis activation markers and proinflammatory markers; and changes in self-reported negative emotional states (depression, anxiety, and stress), sleep quality, and overall quality of life (assessed through Depression Anxiety Stress Scale-21 items, Pittsburgh Sleep Quality Index, and 12-item short-form, respectively) on day 60 and day 120 from baseline. RESULTS: The study was funded in March 2023. The data collection was completed in December 2023. A total of 1660 participants were enrolled in the study. The analysis of the study data is in progress. The study outcomes are expected to be published by December 2026. CONCLUSIONS: This RCT was the first of its kind to explore the potential benefits of using Ayurvedic nutritional supplements and a yoga protocol in conjunction with the standard AS to reduce the occurrence and severity of AMS among healthy personnel. The outcomes of this trial can aid in better acclimatization and resilience among healthy personnel at high altitudes. © Amit Kumar Rai, Sophia Jameela, Arun Kumar Yadav, Rajneesh Kumar Joshi, Pallavi Mundada, Azeem Ahmad, Bidhan Mahajon, Bhagwan Sahai Sharma, Shruti Khanduri, Babita Yadav, Arunabh Tripathi, Rakesh Kumar Rana, Bhogavalli Chandrasekhararao, Narayanam Srikanth, Raghavendra Rao, Rabinarayan Acharya. Originally published in JMIR Research Protocols (https://www.researchprotocols.org). DOI: 10.2196/81567 PMCID: PMC13061369 PMID: 41950501 [Indexed for MEDLINE] Conflict of interest statement: Conflicts of Interest: The authors declare that they have no known competing interests. However, the study protocol, data collection procedures, and analytical framework were jointly developed by the funding agency, CCRAS, and collaborators following internal scientific and ethical review processes. Although CCRAS supported the study infrastructure and data management, the investigators retained full academic independence in interpreting the study findings.

Impact of ashwagandha (Withania somnifera L.) supplementation on serum lipid concentrations and anthropometric parameters in adults with overweight and obesity: a double-blind, placebo-controlled pilot study.

2. Nutr Metab (Lond). 2025 Nov 7;22(1):134. doi: 10.1186/s12986-025-01028-6. Impact of ashwagandha (Withania somnifera L.) supplementation on serum lipid concentrations and anthropometric parameters in adults with overweight and obesity: a double-blind, placebo-controlled pilot study. Ballesteros-Torres JM(1), Vázquez-Aguilar A(2), Luzardo-Ocampo I(3)(4), Escalante-Aburto A(5)(6), Caballero-Prado CJ(7). Author information: (1)Departamento de Microbiología e Inmunología, Facultad de Ciencias Biológicas (FCB), Universidad Autónoma de Nuevo León (UANL), Ave. Universidad s/n, Cd. Universitaria, San Nicolás de los Garza, 66450, N. L, Mexico. (2)Department of Health Sciences, University Center of the Valleys, University of Guadalajara, Ameca, Jalisco, 46600, Mexico. (3)Tecnologico de Monterrey, The Institute for Obesity Research, Av. Eugenio Garza Sada 2501, Col: Tecnológico, Monterrey, 64700, N. L, Mexico. (4)Tecnologico de Monterrey, School of Engineering and Sciences, Av. Eugenio Garza Sada 2501, Col: Tecnológico, Monterrey, 64700, N. L, Mexico. (5)Tecnologico de Monterrey, The Institute for Obesity Research, Av. Eugenio Garza Sada 2501, Col: Tecnológico, Monterrey, 64700, N. L, Mexico. anayansi.escalante@tec.mx. (6)Tecnologico de Monterrey, School of Engineering and Sciences, Av. Eugenio Garza Sada 2501, Col: Tecnológico, Monterrey, 64700, N. L, Mexico. anayansi.escalante@tec.mx. (7)Escuela de Ciencias Aliadas de la Salud, Departamento de Nutrición, Universidad de Monterrey, Av. Morones Prieto 4500 Pte, C. P. 66238, San Pedro Garza García, N. L, Mexico. cindy.caballero@udem.edu. BACKGROUND: Overweight and obesity are widespread in Mexico, often linked to dyslipidemia and higher cardiovascular risk. The search for safe and effective treatments has promoted interest in natural supplements such as Ashwagandha (Withania somnifera), recognized for its adaptogenic and potential lipid-lowering properties. OBJECTIVE: To assess the impact of Ashwagandha supplementation on serum lipid profiles and anthropometric parameters in Mexican adults with overweight and obesity. METHODS: A double-blind, randomized, placebo-controlled pilot clinical trial was carried out with 43 adults (n = 17 in the control group and n = 21 in the intervention group) over 40 days. Participants followed a monitored diet and received one daily capsule containing 500 mg of Ashwagandha or a placebo, in addition to a guided unrestricted dietary plan. Anthropometric and biochemical measurements were taken at baseline and after the intervention. In silico analysis was also performed to examine the binding affinity of Ashwagandha bioactive compounds to key proteins involved in lipid metabolism. RESULTS: Ashwagandha supplementation did not produce statistically significant changes in body weight, body mass index (BMI), or waist circumference (WC). However, significant reductions were observed in triglyceride and VLDL-c levels (p = 0.0082 and p = 0.0321, respectively). In silico results supported these findings, showing favorable interactions between compounds such as withanolide A and lipid metabolism targets, including AMPK, CETP, and LPL. CONCLUSIONS: Ashwagandha supplementation improved serum lipid profiles in adults with overweight and obesity, suggesting potential lipid-lowering effects when combined with a prescribed dietary plan. Also, it was possible to elucidate some metabolic pathways in which Ashwagandha composition has an influence on producing the reported effects. Further long-term studies with controlled dietary intake are needed to confirm these findings and clarify the underlying molecular mechanisms. © 2025. The Author(s). DOI: 10.1186/s12986-025-01028-6 PMCID: PMC12595879 PMID: 41204297 Conflict of interest statement: Declarations. Institutional review board statement: The present study was conducted in accordance with the procedures outlined in the Declaration of Helsinki and was approved by the Committee on Bioethics and Human Dignity of the University of Monterrey, Mexico (2023-01), as well as the research committee (Ref. 20092023-NUT-CI). In addition, the study was registered on ClinicalTrials.gov. ID NCT06676605. Informed consent: The volunteers signed an informed consent form in accordance with the guidelines specified in NOM-012-SSA3-2012. Competing interests: The authors declare no competing interests.

Ashwagandha Does Not Enhance the Effect of High-Intensity Interval Training on Selected Energy Metabolism Parameters in Young Healthy Men.

3. Nutrients. 2025 Oct 16;17(20):3245. doi: 10.3390/nu17203245. Ashwagandha Does Not Enhance the Effect of High-Intensity Interval Training on Selected Energy Metabolism Parameters in Young Healthy Men. Charmas M(1), Jówko E(1), Długołęcka B(1), Klusiewicz A(1), Przybylska I(2), Galczak-Kondraciuk A(3). Author information: (1)Department of Physiology and Biochemistry, Faculty of Physical Education and Health in Biała Podlaska, University of Physical Education in Warsaw, 00-968 Warsaw, Poland. (2)Regional Research and Development Centre, Faculty of Physical Education and Health in Biała Podlaska, University of Physical Education in Warsaw, 00-968 Warsaw, Poland. (3)Department of Health Promotion, Faculty of Physical Education and Health in Biała Podlaska, University of Physical Education in Warsaw, 00-968 Warsaw, Poland. BACKGROUND/OBJECTIVES: High-intensity interval training (HIIT) is considered an effective way in improving aerobic capacity and selected health parameters. Ashwagandha is an herb with possible health-promoting properties that may affect metabolism and performance. The aim of this study was to evaluate the effects of ashwagandha supplementation (600 mg/day) during an 8-week HIIT on body composition, lipid profile and hormone levels related to energy homeostasis in healthy young men. METHODS: The study was randomised, double-blind and placebo-controlled (Placebo group, PL, n = 20; ashwagandha, A, n = 18). HIIT was conducted on a rowing ergometer (3 times per week, 5-7 series of 1.5 min at 85-95% of maximum power, with intervals of 1.5 min at 70 W). Body composition (BIA, Tanita TBF 300P), serum lipid profile (tChol, HDL-cholesterol, LDL-cholesterol, TG) and serum levels of adiponectin, asprosin and irisin were analysed before (term 1) and after the8-week study (term 2). Both the lipid and hormonal profiles were measured in three time points: pre- and post-graded exercise test and after 24 h recovery period. RESULTS: Analysis showed no effect of training or supplementation on body composition and lipid profile (p > 0.05). In turn, the 8-week HIIT decreased resting levels of adiponectin and increased irisin levels post-exercise and after 24 h (p < 0.05). CONCLUSIONS: In young, healthy men, an 8-week HIIT programme significantly affects selected hormones related to energy metabolism of adipose (adiponectin) and muscle (irisin) tissues, but ashwagandha supplementation did not significantly affect any of the hormonal parameters analysed. DOI: 10.3390/nu17203245 PMCID: PMC12566838 PMID: 41156498 [Indexed for MEDLINE] Conflict of interest statement: The authors declare no conflicts of interest.

Lowering plasma S-Adenosylhomocysteine (SAH) in healthy adults with elevated SAH and normal homocysteine using nutritional supplementation.

4. Nutr Metab Cardiovasc Dis. 2025 Dec;35(12):104221. doi: 10.1016/j.numecd.2025.104221. Epub 2025 Jul 5. Lowering plasma S-Adenosylhomocysteine (SAH) in healthy adults with elevated SAH and normal homocysteine using nutritional supplementation. Pohl F(1), Dominique A(1), Dufour J(2), Wang J(2), Lin XL(2), Sharif B(2), Wilson M(1), Gonzalez L(1), El-Khodor BF(3). Author information: (1)Nutrition Innovation Center, Standard Process Inc., Kannapolis, NC, USA. (2)Nutrasource Pharmaceutical and Nutraceutical Services Inc., Guelph, Ontario, Canada. (3)Nutrition Innovation Center, Standard Process Inc., Kannapolis, NC, USA. Electronic address: belkhodor@standardprocess.com. BACKGROUND AND AIMS: Elevated plasma levels of total homocysteine (Hcy) and S-Adenosylhomocysteine (SAH) are associated with increased risks of neurological and cardiovascular diseases (CVD). Whilst elevated plasma levels of Hcy can be managed through supplementation with B-group vitamins, there are no effective therapies for managing SAH in patients with elevated SAH and normal Hcy. SAH, a by-product of cellular methylation reactions, is considered a more sensitive biomarker for CVD than homocysteine (Hcy). The aim of this study was to determine if a test product containing ashwagandha extract, alpha-glycerylphosphorylcholine and creatine monohydrate, could lower plasma SAH levels in adults with elevated SAH and normal Hcy. METHODS AND RESULTS: In this prospective, randomized, single-blind, placebo-controlled clinical trial, 40 participants with elevated SAH (≥20 nmol/L) and normal Hcy (≤13 μmol/L) were randomized into two groups: 15 participants received the placebo, and 25 participants received the test product. The test product significantly lowered plasma SAH levels by approximately 12% and increased S-Adenosylmethionine (SAM): SAH ratio by approximately 26% after 12 weeks of supplementation compared to baseline. The test product was safe and well-tolerated, with no serious adverse events. No clinically relevant changes in vital signs and safety laboratory parameters were detected. CONCLUSION: This is the first demonstration of a nutritional product's effectiveness in decreasing plasma levels of SAH in otherwise healthy individuals with elevated SAH and normal Hcy. Hence, this test product offers a unique opportunity for investigating the impact of lowering plasma SAH on the risk of developing CVD and other diseases. Clincaltrial.gov registration: NCT05994794, 2023-08-16. Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved. DOI: 10.1016/j.numecd.2025.104221 PMID: 40883125 [Indexed for MEDLINE] Conflict of interest statement: Conflict of interest B. F. El-K., F. P., M.W., A.D., and L.G. are current employees of Standard Process Inc. J. D., J. W., L. L. and B. S. are employees of Nutrasource Pharmaceutical and Nutraceutical Services Inc. - a Contract Research Organization (CRO) that was sponsored by Standard Process Inc. to independently conduct this study.

Randomized, Double-Blind, Crossover Study Comparing the Bioavailability of 4 Ashwagandha (Withania somnifera (L.) Dunal) Extracts in Healthy Adults Under Fasting Condition.

5. Curr Ther Res Clin Exp. 2025 Jul 10;103:100805. doi: 10.1016/j.curtheres.2025.100805. eCollection 2025. Randomized, Double-Blind, Crossover Study Comparing the Bioavailability of 4 Ashwagandha (Withania somnifera (L.) Dunal) Extracts in Healthy Adults Under Fasting Condition. Rathi P(1), Kim SK(2). Author information: (1)Synergen Bio Private Limited, Pune, Maharashtra, India. (2)College of Science & Technology, Hanyang University, ERICA Campus, Ansan, Republic of Korea. BACKGROUND: Withania somnifera (L.) Dunal, commonly known as ashwagandha, is a well-known plant in ayurvedic medicine, widely valued for its therapeutic potential. Although numerous clinical studies have explored its diverse health benefits, limited data are available on the pharmacokinetic (PK) properties and comparative bioavailability of its key bioactive constituents in humans. OBJECTIVE: This study aimed to evaluate and compare the oral bioavailability of 4 commercially standardized ashwagandha extracts under fasting conditions in healthy adults. METHODS: This randomized, double-blind, 4-treatment, 4-period, 4-sequence, single dose, 4-way crossover study was conducted in 16 healthy human volunteers. Participants received a single oral dose of 1 of 4 ashwagandha extracts, with varying compositions of 35% (Withania somnifera [WS]-35) or 10% (WS-10) withanolide glycosides, or 5% (WS-5) or 2.5% (WS-2.5) withanolides, each standardized to deliver 185 mg of total withanolides. Seventeen blood samples were collected over a 24-hour period after dose administration. Plasma concentrations of withanolide A, withanoside IV, withaferin A, and total withanolides were quantified, and PK parameters were calculated. RESULTS: Withania somnifera-35 had significantly superior bioavailability compared with the other extracts. The AUC0-t for total withanolides per gram of WS-35 was 118.28, 226.11, and 267.83 times better than WS-10, WS-5, and WS-2.5 respectively. Withania somnifera-35 exhibited a significantly higher Cmax, longer half-life, extended mean residence time, and lower systemic clearance, attributable to its higher withanolide glycoside content. CONCLUSIONS: These findings emphasize the critical role of withanolide glycosides in determining the PK performance of ashwagandha supplements. The enhanced bioavailability of WS-35 supports its preferential use in therapeutic applications and provides a strong rationale for further investigation into dose-response relationships and the long-term efficacy of standardized, high-bioavailability formulations. Clinical Trial Registry of India identifier: CTRI/2020/10/028397. © 2025 The Authors. DOI: 10.1016/j.curtheres.2025.100805 PMCID: PMC12337022 PMID: 40792075 Conflict of interest statement: The 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.

Superior Bioavailability of a Novel 1.5% Ashwagandha Formulation (Zenroot™): A Randomized, Double-Blind, Single-Dose, Comparative, Oral Bioavailability Study in Healthy Adults.

6. Adv Ther. 2025 Oct;42(10):4964-4976. doi: 10.1007/s12325-025-03292-7. Epub 2025 Aug 1. Superior Bioavailability of a Novel 1.5% Ashwagandha Formulation (Zenroot™): A Randomized, Double-Blind, Single-Dose, Comparative, Oral Bioavailability Study in Healthy Adults. Ramapalaniappan A(1), Loganathan V(1), Morde A(2), Padigaru M(2), Patni P(2), Joshua L(3), Thomas JV(4). Author information: (1)Spinos Life Science and Research Private Limited, 29 A, Krishna Madura Vanam, Vellakinar Pirivu, Thudiyalur, Coimbatore, 641029, Tamil Nadu, India. (2)OmniActive Health Technologies, Phoenix House, T-8, A Wing 462 Senapati Bapat Marg, Lower Parel, Mumbai, 400 013, Maharashtra, India. (3)Leads Clinical Research and Bio Services Pvt. Ltd., No. 9, 1st Floor Mythri Legacy, Kalyan Nagar, Chelekere Main Road, Bengaluru, 560043, Karnataka, India. (4)Leads Clinical Research and Bio Services Pvt. Ltd., No. 9, 1st Floor Mythri Legacy, Kalyan Nagar, Chelekere Main Road, Bengaluru, 560043, Karnataka, India. jestin@leadsbio.com. INTRODUCTION: Ashwagandha has multiple medicinal properties and is widely used as a supplement to address various health conditions including stress and anxiety. The bioavailability of Ashwagandha bioactives provide critical information on the biological effects in humans after oral supplementation. METHODS: A randomized, double-blind, single-dose, cross-over comparative oral bioavailability study was conducted in 20 healthy, adult human subjects under fasting conditions. All subjects consumed single dose of ZEN 1.5 (Zenroot™ Ashwagandha 1.5% 125 mg), ASH 5 (Reference product 1-Ashwagandha 5% 600 mg) and ASH 10 (Reference product 2-Ashwagandha 10% 500 mg) as per a randomization schedule. Blood samples were collected at 0.00 h, and at 00.25, 00.50, 00.75, 01.00, 02.00, 03.00, 04.00, 05.00, 06.00, 09.00, 12.00, and 24.00 h post-dose. Total withanolides (consisting of withanoside IV, withanolide A, 12-deoxywithastramonolide, and withaferin A) were quantified in plasma using the LC-MS/MS method and pharmacokinetics parameters like area under the curve, AUC0-t, Cmax, Tmax, t½ and test/reference (T/R) ratio for test product, ZEN 1.5, versus reference products, ASH 5 and ASH 10, were used for statistical comparisons. RESULTS: Subjects in the ZEN 1.5 group showed significantly (P < 0.05) higher total withanolides concentration in plasma at all post-dose time points except 12.00 and 24.00 h compared to ASH 5. In addition, subjects in Ashwagandha ZEN 1.5 group showed significantly higher (P < 0.05) total withanolides concentration in plasma at 0.25, 1.00, 2.00, 3.0, and 4.00 h compared to ASH 10. Further, ZEN 1.5 showed significantly higher bioavailability for total withanolides compared to ASH 5 and ASH 10 with significantly higher (P < 0.05) Cmax and AUC0-t parameters, T/R ratio, and 90% CI. ZEN 1.5 at 125-mg dose showed 2.1-fold higher bioavailability compared to ASH 5 at 600 mg, and 1.3-fold higher bioavailability compared to ASH 10 at 500 mg. ZEN 1.5 was well tolerated during the study period. CONCLUSION: A low dose of 125 mg of ZEN 1.5 showed greater total withanolides bioavailability compared to reference products. The Cmax and AUC parameters were significantly higher than the 80-125% criteria established by the FDA for bioequivalence confirming superior bioavailability of ZEN 1.5. In addition, ZEN 1.5 was well tolerated by subjects throughout the study duration. Further studies are warranted for evaluating the health benefits of ZEN 1.5. TRIAL REGISTRATION: CTRI/2022/11/047039. © 2025. The Author(s). DOI: 10.1007/s12325-025-03292-7 PMCID: PMC12474700 PMID: 40748423 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Conflict of Interest: Muralidhara Padigaru, Abhijeet Morde, and Paras Patni are employees of OmniActive Health Technologies Limited. R Abiraamasundari, L Vijayakrishnan, Lincy Joshua, and Jestin V. Thomas 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. Ethical Approval: Institutional ethics approval was obtained from ‘The Research Ethics Committee’ Coimbatore, India. This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with the International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, as well as in strict compliance with the “The New Drugs and Clinical Trial Rules- 2019”, the Ministry of Health and Family Welfare and the Government of India at all stages of the trial for adherence to protocol and compliance with ethical and regulatory guidelines. Voluntary consent was obtained in written from all the study participants before commencing any study related activities. The EC was duly apprised of the progress and updates of the trial at regular intervals as per prescribed guidelines.

Dual impact of Ashwagandha: Significant cortisol reduction but no effects on perceived stress - A systematic review and meta-analysis.

7. Nutr Health. 2025 Dec;31(4):1395-1408. doi: 10.1177/02601060251363647. Epub 2025 Aug 1. Dual impact of Ashwagandha: Significant cortisol reduction but no effects on perceived stress - A systematic review and meta-analysis. Albalawi AA(1). Author information: (1)Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences, University of Tabuk, Tabuk, Kingdom of Saudi Arabia. BackgroundThe global medicine market is projected to reach US$417 billion by 2033, reflecting rising demand for natural healthcare alternatives. Ashwagandha (Withania somnifera) is widely used in Ayurvedic medicine for stress management, but evidence supporting its efficacy remains inconsistent.AimThis systematic review and meta-analysis evaluated Ashwagandha's impact on cortisol levels (a biological stress marker) and perceived stress via Perceived Stress Scale (PSS) scores across randomized controlled trials (RCTs).MethodPRISMA guidelines were followed. Four databases (PubMed, CINAHL, Google Scholar, and Scopus) were searched for studies from January 2012 to February 2024, yielding seven studies on cortisol and six on perceived stress (n = 488 participants). Inclusion criteria were RCTs longer than or equal to two weeks, oral doses ≥250 mg/day, and reporting cortisol and PSS outcomes. The Cochrane Risk of Bias 2 tool was used to assess the risk of bias.ResultsThere was a statistically significant reduction in cortisol levels (-1.16 µg/dL, 95% CI: -1.64 to -0.69, P < 0.001). No significant impact was observed on perceived stress (SMD = -0.355, 95% CI: -1.188 to 0.47; P = 0.40). Heterogeneity was moderate (I2 = 50.9%). However, no statistically significant impact was observed on perceived stress (SMD = -0.355, 95% CI: -1.188 to 0.47; P-value = 0.40). The heterogeneity among studies was moderate (I2 = 50.9%). Risk of bias was generally moderate; most studies reported adequate randomization, but some lacked allocation concealment. No publication bias was detected.ConclusionFindings support Ashwagandha's role in lowering cortisol, but gaps remain regarding long-term safety, dosing, and effectiveness across diverse populations. The disconnect between cortisol and PSS outcomes highlights the need for longer treatment duration and broader demographic inclusion. Longitudinal research is recommended to validate Ashwagandha as a holistic stress management tool. DOI: 10.1177/02601060251363647 PMID: 40746175 [Indexed for MEDLINE] Conflict of interest statement: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Effectiveness of a Saffron and Withania Supplement on Mood in Women With Mild-to-Moderate Anxiety During the COVID-19 Lockdown.

8. Depress Anxiety. 2024 Nov 11;2024:3661412. doi: 10.1155/2024/3661412. eCollection 2024. Effectiveness of a Saffron and Withania Supplement on Mood in Women With Mild-to-Moderate Anxiety During the COVID-19 Lockdown. Pages-García C(1), De Almagro MC(2), Ruiz-Moreno J(3), De Castellar R(4). Author information: (1)Obstetrics and Gynecology Department, Hospital Universitario, Toledo, Hospitales de Madrid HM IMI Toledo, Unidad de Suelo Pélvico, Toledo, Spain. (2)Parc Científic de Barcelona, Laboratorios Ordesa S.L., Barcelona 08028, Spain. (3)Head of Biometry, Mixestat S.L., Barcelona 08021, Spain. (4)Clinical Research Unit, Medical Affairs Department, Laboratorios Ordesa S.L, Barcelona 08038, Spain. Background: A nutritional supplement based on medicinal plants (saffron and ashwagandha), tryptophan, and vitamin B6 could contribute to alleviating/improving mood and associated disorders. The aim of this study was to evaluate the potential benefits of this combination supplement. During the study period, participants underwent a period of forced home confinement due to the COVID-19 pandemic, which represented an unexpected impact factor. Methods: This open-label prospective trial enrolled a cohort of female employees who reported mild to moderate anxiety. The primary objective was to evaluate changes in the level of anxiety using the adapted Hamilton Anxiety Rating Scale (HARS) after 12 weeks of regular supplementation with Safromotive (two tablets daily, for 12 weeks). The secondary objectives were to evaluate health-related quality of life (HRQoL) and tolerability. Results: In total, 46 women with a mean age of 45.0 (6.5) years were included. A statistically significant improvement in HARS was observed, with a 7.5-unit decrease from baseline to 12 weeks (p  < 0.0001) and from 4 to 12 weeks of supplement intake (p=0.0058). However, no significant changes were found during the lockdown period (between weeks 8 and 12 of the study). No relationship was found between women's sociodemographic characteristics and the HARS total score. A significant reduction in the HRQoL questionnaire score of 1.2 units was observed between baselines and 12 weeks of treatment (p=0.0273). At the end of the study, 78.6% of the women reported consistency the supplement intake during the study course. Conclusion: This nutritional supplement composed of saffron, ashwagandha, tryptophan, and vitamin B6 appears to improve anxiety and HRQoL, but confinement could have impacted the evolution of the outcome. Copyright © 2024 Cristina Pages-García et al. DOI: 10.1155/2024/3661412 PMCID: PMC11919007 PMID: 40226680 [Indexed for MEDLINE] Conflict of interest statement: M. Cristina De Almagro and Roser De Castellar are employees of Laboratorios Ordesa S.L. The rest of the authors declare no conflicts of interest.

Short-term influence of Immufen™ on mild allergic rhinitis: a randomized, double-blind, placebo-controlled study.

9. Front Allergy. 2024 Oct 14;5:1390813. doi: 10.3389/falgy.2024.1390813. eCollection 2024. Short-term influence of Immufen™ on mild allergic rhinitis: a randomized, double-blind, placebo-controlled study. K M(1), Aryan MK(2), Prabhakaran P(3), Mulakal JN(3), Das S S(3), Im K(3), Parameswara Panicker S(4). Author information: (1)Department of General Medicine, Divakar's Specialty Hospital, Bengaluru, India. (2)Department of Immunology, Amala Cancer Research Centre, Thrissur, India. (3)R&D Centre, Akay Natural Ingredients, Kochi, India. (4)Department of Zoology, Advanced Centre for Regenerative Medicine and Stem Cell Research in Cutaneous Biology (AcREM-STEM), University of Kerala, Kariavattom, Thiruvananthapuram, India. INTRODUCTION: Allergic rhinitis (AR) is an IgE-mediated reaction to inhaled allergens, and is a prominent health concern affecting approximately 400 million people worldwide. A comprehensive understanding of AR's pathophysiology is imperative for developing novel therapies, especially considering its frequent co-morbidity with asthma and conjunctivitis. The escalating prevalence of AR is correlated with increased urbanization and environmental pollutants, recognized as prominent contributing factors. Dysregulation in immune networks, Th1/Th2 cytokine imbalance, activation of mast cells and eosinophils are implicated in AR progression. Classic AR symptoms include nasal congestion, nasal itching, rhinorrhea, and sneezing which significantly impact the quality of life, social interactions, and workplace productivity. METHODS: This randomized, double-blind, placebo-controlled, three-arm, three-sequence study was aimed to assess the efficacy of supplementation of a co-delivery form of turmeric extract with ashwagandha extract (CQAB) in comparison with a bioavailable curcumin (CGM) and placebo in alleviating AR symptoms and enhancing the quality of life in individuals with mild AR. Participants received either placebo, CGM, or CQAB twice/day for 28 days, and subjective measures were recorded at the baseline and at the end of study. RESULTS: CQAB supplementation demonstrated a significant (P < 0.05) improvement in Total Nasal Symptom Score (TNSS) compared to placebo and CGM. Furthermore, CQAB administration resulted in enhanced sleep quality (P < 0.05) as evaluated by the BIS questionnaire, heightened energy levels, and decreased fatigue and overall mood disturbance (POMS-SF) compared to both placebo and CGM. CONCLUSION: The results suggests that CQAB has the potential to be used as a dietary supplement in alleviating AR discomforts. CLINICAL TRIAL REGISTRATION: https://ctri.nic.in/Clinicaltrials/login.php; Identifier CTRI/2021/01/030355. © 2024 K, Aryan, Prabhakaran, Mulakal, Das S, IM and Parameswara Panicker. DOI: 10.3389/falgy.2024.1390813 PMCID: PMC11513368 PMID: 39469483 Conflict of interest statement: The authors declare that this study received funding from Akay Natural Ingredients. PP, JM, SD and KIM were employed by Akay Natural Ingredients. 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.

Nutraceuticals and phytoceuticals in the treatment of schizophrenia: a systematic review and network meta-analysis "Nutra NMA SCZ".

10. Mol Psychiatry. 2025 Jan;30(1):168-187. doi: 10.1038/s41380-024-02645-y. Epub 2024 Jul 18. Nutraceuticals and phytoceuticals in the treatment of schizophrenia: a systematic review and network meta-analysis "Nutra NMA SCZ". Fornaro M(#)(1), Caiazza C(#)(2), Billeci M(2), Berk M(3)(4)(5)(6)(7), Marx W(8), Balanzá-Martinez V(9), De Prisco M(10), Pezone R(2), De Simone G(2), Solini N(2), Iasevoli F(2)(11), Berna F(12), Fond G(13)(14), Boyer L(13)(14), Carvalho AF(15), Dragioti E(16), Fiedorowicz JG(17)(18)(19), de Bartolomeis A(2)(11), Correll CU(20)(21)(22)(23), Solmi M(17)(18)(19)(23). Author information: (1)Department of Neuroscience, Reproductive Sciences, and Dentistry, Section of Psychiatry, University School of Medicine Federico II, Naples, Italy. dott.fornaro@gmail.com. (2)Department of Neuroscience, Reproductive Sciences, and Dentistry, Section of Psychiatry, University School of Medicine Federico II, Naples, Italy. (3)Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation Strategic Research Centre, School of Medicine, Geelong, VIC, Australia. (4)Mental Health Drug and Alcohol Services, Barwon Health, Geelong, VIC, Australia. (5)Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, VIC, Australia. (6)Centre for Youth Mental Health, Florey Institute for Neuroscience and Mental Health, Melbourne, VIC, Australia. (7)Department of Psychiatry, The University of Melbourne, Melbourne, VIC, Australia. (8)Food & Mood Centre, Deakin University, IMPACT (the Institute for Mental and Physical Health and Clinical Translation), Geelong, VIC, Australia. (9)Teaching Unit of Psychiatry and Psychological Medicine, Department of Medicine, Centro de Investigación Biomédica En Red de Salud Mental (CIBERSAM), University of Valencia, Valencia, Spain. (10)Bipolar and Depressive Disorders Unit, Institute of Neuroscience, Hospital Clinic, CIBERSAM, University of Barcelona, IDIBAPS, Barcelona, Catalonia, Spain. (11)Section of Psychiatry, Laboratory of Translational and Molecular Psychiatry and Unit of Treatment-Resistant Psychosis, Department of Neuroscience, Reproductive Sciences and Odontostomatology, University Medical School of Naples "Federico II", Naples, Italy. (12)Department of Psychiatry, Strasbourg University Hospital, University of Strasbourg, Strasbourg, France. (13)CEReSS-Health Service Research and Quality of Life Center, UR3279, Assistance Publique des Hôpitaux de Marseille, Aix-Marseille University, Marseille, France. (14)Fondation FondaMental Fondation de Coopération Scientifique en Santé Mentale, Université Paris Est, Créteil, France. (15)Innovation in Mental and Physical Health and Clinical Treatment (IMPACT) Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, VIC, Australia. (16)Pain and Rehabilitation Center, Department of Medicine and Health Sciences, Linköping University, Linköping, Sweden. (17)Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada. (18)Department of Mental Health, The Ottawa Hospital, Ottawa, ON, Canada. (19)Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada. (20)Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA. (21)Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA. (22)Center for Psychiatric Neuroscience, Feinstein Institute for Medical Research, Manhasset, NY, USA. (23)Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany. (#)Contributed equally Update of Res Sq. 2024 Jan 12:rs.3.rs-3787917. doi: 10.21203/rs.3.rs-3787917/v1. Sub-optimal response in schizophrenia is frequent, warranting augmentation strategies over treatment-as-usual (TAU). We assessed nutraceuticals/phytoceutical augmentation strategies via network meta-analysis. Randomized controlled trials in schizophrenia/schizoaffective disorder were identified via the following databases: PubMed, MEDLINE, EMBASE, Scopus, PsycINFO, CENTRAL, and ClinicalTrials.gov. Change (Standardized Mean Difference = SMD) in total symptomatology and acceptability (Risk Ratio = RR) were co-primary outcomes. Secondary outcomes were positive, negative, cognitive, and depressive symptom changes, general psychopathology, tolerability, and response rates. We conducted subset analyses by disease phase and sensitivity analyses by risk of bias and assessed global/local inconsistency, publication bias, risk of bias, and confidence in the evidence. The systematic review included 49 records documenting 50 studies (n = 2384) documenting 22 interventions. Citicoline (SMD =-1.05,95%CI = -1.85; -0.24), L-lysine (SMD = -1.04,95%CI = -1.84; -0.25), N-acetylcysteine (SMD = -0.87, 95%CI = -1.27; -0.47) and sarcosine (SMD = -0.5,95%CI = -0.87-0.13) outperformed placebo for total symptomatology. High heterogeneity (tau2 = 0.10, I2 = 55.9%) and global inconsistency (Q = 40.79, df = 18, p = 0.002) emerged without publication bias (Egger's test, p = 0.42). Sarcosine improved negative symptoms (SMD = -0.65, 95%CI = -1.10; -0.19). N-acetylcysteine improved negative symptoms (SMD = -0.90, 95%CI = -1.42; -0.39)/general psychopathology (SMD = -0.76, 95%CI = -1.39; -0.13). No compound improved total symptomatology within acute phase studies (k = 7, n = 422). Sarcosine (SMD = -1.26,95%CI = -1.91; -0.60), citicoline (SMD = -1.05,95%CI = -1.65;-0.44), and N-acetylcysteine (SMD = -0.55,95%CI = -0.92,-0.19) outperformed placebo augmentation in clinically stable participants. Sensitivity analyses removing high-risk-of-bias studies confirmed overall findings in all phases and clinically stable samples. In contrast, the acute phase analysis restricted to low risk-of-bias studies showed a superior effect vs. placebo for N-acetylcysteine (SMD = -1.10, 95%CI = -1.75,-0.45), L-lysine (SMD = -1.05,95%CI = -1.55, -0.19), omega-3 fatty acids (SMD = -0.83,95%CI = -1.31, -0.34) and withania somnifera (SMD = -0.71,95%CI = -1.21,-0.22). Citicoline (SMD = -1.05,95%CI = -1.86,-0.23), L-lysine (SMD = -1.04,95%CI = -1.84,-0.24), N-acetylcysteine (SMD = -0.89,95%CI = -1.35,-0.43) and sarcosine (SMD = -0.61,95%CI = -1.02,-0.21) outperformed placebo augmentation of TAU ("any phase"). Drop-out due to any cause or adverse events did not differ between nutraceutical/phytoceutical vs. placebo+TAU. Sarcosine, citicoline, and N-acetylcysteine are promising augmentation interventions in stable patients with schizophrenia, yet the quality of evidence is low to very low. Further high-quality trials in acute phases/specific outcomes/difficult-to-treat schizophrenia are warranted. © 2024. The Author(s), under exclusive licence to Springer Nature Limited. DOI: 10.1038/s41380-024-02645-y PMID: 39026098 [Indexed for MEDLINE] Conflict of interest statement: Competing interests: MF received honoraria for his speaker activity from the American Society of Clinical Psychopharmacology (ASCP) and served as a consultant for Angelini, Otsuka, Lundbeck, Sanofi-Aventis, and Boehringer Ingelheim. WM has previously received university grants/fellowships from La Trobe University, Deakin University, University of Queensland, and Bond University. WM has received funding and/or has attended events funded by Cobram Estate Pty. Ltd and Bega Dairy and Drinks Pty Ltd. WM has received travel funding from the Nutrition Society of Australia. WM has received consultancy funding from Nutrition Research Australia and ParachuteBH. MS has received honoraria/has been a consultant for AbbVie, Angelini, Lundbeck, and Otsuka. VBM received honoraria from Angelini, unrelated to the present work. CUC has been a consultant and/or advisor to or has received honoraria from: AbbVie, Acadia, Adock Ingram, Alkermes, Allergan, Angelini, Aristo, Biogen, Boehringer-Ingelheim, Bristol-Meyers Squibb, Car dio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Delpor, Denovo, Gedeon Richter, Hikma, Holmusk, IntraCellular Therapies, Jamjoom Pharma, Janssen/J&J, Karuna, LB Pharma, Lundbeck, MedAvante-ProPhase, MedInCell, Merck, Mindpax, Mitsubishi Tanabe Pharma, Mylan, Neurocrine, Neurelis, Newron, Noven, Novo Nordisk, Otsuka, Pharmabrain, PPD Biotech, Recordati, Relmada, Reviva, Rovi, Sage, Seqirus, SK Life Science, Sumitomo Pharma America, Sunovion, Sun Pharma, Supernus, Tabuk, Takeda, Teva, Tolmar, Vertex, and Viatris. He provided expert testimony for Janssen and Otsuka. He served on a Data Safety Monitoring Board for Compass Pathways, Denovo, Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva. He has received grant support from Janssen and Takeda. He received royalties from UpToDate and is also a stock option holder of Cardio Diagnostics, Kuleon Biosciences, LB Pharma, Mindpax, and Quantic. All other authors declare no conflicts of interest relevant to this work.

Acute and Repeated Ashwagandha Supplementation Improves Markers of Cognitive Function and Mood.

11. Nutrients. 2024 Jun 8;16(12):1813. doi: 10.3390/nu16121813. Acute and Repeated Ashwagandha Supplementation Improves Markers of Cognitive Function and Mood. Leonard M(1), Dickerson B(1), Estes L(1), Gonzalez DE(1), Jenkins V(1), Johnson S(1), Xing D(1), Yoo C(1), Ko J(1), Purpura M(2), Jäger R(2), Faries M(1)(3), Kephart W(4), Sowinski R(1), Rasmussen CJ(1), Kreider RB(1). Author information: (1)Exercise & Sport Nutrition Lab, Department of Kinesiology and Sports Management, Texas A&M University, College Station, TX 77843, USA. (2)Increnovo LLC, Whitefish Bay, WI 53217, USA. (3)Texas A&M AgriLife Extension, Texas A&M University, College Station, TX 77843, USA. (4)Department of Kinesiology, University of Wisconsin-Whitewater, Whitewater, WI 53190, USA. BACKGROUND: Ashwagandha has been reported to reduce stress and attenuate cognitive decline associated with inflammation and neurodegeneration in clinical populations. However, the effects as a potential nootropic nutrient in younger populations are unclear. This study examined the effects of liposomal ashwagandha supplementation on cognitive function, mood, and markers of health and safety in healthy young men and women. METHODS: 59 men and women (22.7 ± 7 yrs., 74.9 ± 16 kg, 26.2 ± 5 BMI) fasted for 12 h, donated a fasting blood sample, and were administered the COMPASS cognitive function test battery (Word Recall, Word recognition, Choice Reaction Time Task, Picture Recognition, Digit Vigilance Task, Corsi Block test, Stroop test) and profile of mood states (POMS). In a randomized and double-blind manner, participants were administered 225 mg of a placebo (Gum Arabic) or ashwagandha (Withania somnifera) root and leaf extract coated with a liposomal covering. After 60-min, participants repeated cognitive assessments. Participants continued supplementation (225 mg/d) for 30 days and then returned to the lab to repeat the experiment. Data were analyzed using a general linear model (GLM) univariate analysis with repeated measures and pairwise comparisons of mean changes from baseline with 95% confidence intervals (CI). RESULTS: Ashwagandha supplementation improved acute and/or 30-day measures of Word Recall (correct and recalled attempts), Choice Reaction Time (targets identified), Picture Recognition ("yes" correct responses, correct and overall reaction time), Digit Vigilance (correct reaction time), Stroop Color-Word (congruent words identified, reaction time), and POMS (tension and fatigue) from baseline more consistently with several differences observed between groups. CONCLUSION: Results support contentions that ashwagandha supplementation (225 mg) may improve some measures of memory, attention, vigilance, attention, and executive function while decreasing perceptions of tension and fatigue in younger healthy individuals. Retrospectively registered clinical trial ISRCTN58680760. DOI: 10.3390/nu16121813 PMCID: PMC11207027 PMID: 38931168 [Indexed for MEDLINE] Conflict of interest statement: R.J. and M.P. are principals and researchers affiliated with Increnovo. They were not involved in the data collection or analysis. R.B.K. served as Principal Investigator at the study location. He has conducted sponsored grants and contracts awarded to the universities with which he has been affiliated, received an honorarium for making scientific presentations, served as an expert on legal cases, and consulted with industry on product development unrelated to the product studied. He has no financial or intellectual property-related conflict of interest with the study sponsor or nutrient examined. Other authors report no conflicts.

Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study.

12. Front Nutr. 2024 Jun 3;11:1403108. doi: 10.3389/fnut.2024.1403108. eCollection 2024. Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study. Pérez-Piñero S(1), Muñoz-Carrillo JC(1), Echepare-Taberna J(1), Luque-Rubia AJ(1), Millán Rivero JE(1), Muñoz-Cámara M(1), Díaz Silvente MJ(2), Valero Merlos E(3), Ávila-Gandía V(1), Caturla N(4), Navarro P(4), Cabrera M(4), López-Román FJ(1)(5). Author information: (1)Faculty of Medicine, UCAM Universidad Católica San Antonio de Murcia, Murcia, Spain. (2)Health Sciences PhD Program, UCAM Universidad Católica San Antonio de Murcia, Murcia, Spain. (3)Faculty of Nursing, UCAM Universidad Católica San Antonio de Murcia, Murcia, Spain. (4)Monteloeder S.L., Elche, Spain. (5)Primary Care Research Group, Biomedical Research Institute of Murcia (IMIB-Arrixaca), Murcia, Spain. BACKGROUND: Back pain is a common health problem that affects both workers and older people, reducing their quality of life. The primary objective was to assess the effect of dietary supplementation with plant extracts of rosemary, ashwagandha, and sesame consumed for 12 weeks on the intensity of back pain. METHODS: A single-center randomized double-blind study with three parallel arms depending on the product consumed. The duration of treatment was 12 weeks. The investigational product, Berelief®, contained a blend of three polyphenolic standardized extracts: rosemary (Rosmarinus officinalis L.), ashwagandha (Withania somnifera L.), and sesame (Sesamum indicum L.) seed. Two doses were tested: low dose (400 mg) and high dose (800 mg). There were 42 subjects in the placebo group, 39 in the low dose and 42 in the high dose groups. Study variables included back pain intensity [VAS score, Patient-Reported Outcomes Measurement Information System (PROMIS-29), and Cornell Musculoskeletal Discomfort Questionnaire; functionality Roland-Morris Disability (RMD) questionnaire]; quality of life (QoL) [36-item Short Form Survey (SF-36), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Perceived Stress Scale (PSS)]; sleep quality [accelerometer and Pittsburgh Sleep Quality Index (PSQI)]. RESULTS: The improvement in back pain recorded by the visual analogue scale (VAS) at the study visits after the beginning of treatment, as well as on a weekly basis recorded in the diary card was significantly higher in the intervention group than in the placebo group (p < 0.044 dose-low; p < 0.005 dose-high). Significant differences in pain intensity of the PROMIS-29 (p = 0.002) and upper back pain in the Cornell questionnaire (p = 0.011) in favour of the investigational product were found. Furthermore, benefits in improving health-related quality of life, mood and sleep quality were also detected. CONCLUSION: Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain. Copyright © 2024 Pérez-Piñero, Muñoz-Carrillo, Echepare-Taberna, Luque-Rubia, Millán Rivero, Muñoz-Cámara, Díaz Silvente, Valero Merlos, Ávila-Gandía, Caturla, Navarro, Cabrera and López-Román. DOI: 10.3389/fnut.2024.1403108 PMCID: PMC11182357 PMID: 38887495 Conflict of interest statement: NC, PN, MC, and FJL-R were employed by the Monteloeder S.L. 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.