{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T06:07:42Z","timestamp":1788934062835,"version":"build-2803163510"},"reference-count":49,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Nutr."],"abstract":"\n Introduction<\/jats:title>\n \n Previous studies suggest that conventional Ashwagandha (\n Withania somnifera<\/jats:italic>\n ) root extracts may improve physical performance in both athletic and non-athletic populations. However, evidence on sustained-release ashwagandha formulations is lacking. This randomized double-blind, placebo-controlled trial evaluated the safety and efficacy of sustained-release ashwagandha root extract (AshwaSR) 300\u202fmg in improving muscle strength in recreationally active healthy individuals.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Eligible participants aged 25\u201350\u202fyears received AshwaSR 300\u202fmg or placebo capsules once daily for 90\u202fdays. Changes in one-repetition maximum (1-RM) bench press, maximal oxygen uptake (VO\n 2<\/jats:sub>\n max), serum testosterone, creatine kinase (CK) and lactate dehydrogenase (LDH) concentrations, and quality of life (QoL using SF-12 questionnaire) from baseline till study end were evaluated.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 84 enrolled participants, 83 completed the study (AshwaSR,\n n<\/jats:italic>\n \u202f=\u202f41; Placebo,\n n<\/jats:italic>\n \u202f=\u202f42). Compared with placebo, participants receiving AshwaSR demonstrated significantly greater improvements in muscle strength and cardiorespiratory endurance starting from day 30 (1-RM: 4.69 vs. 2.23\u202fkg; VO\n 2<\/jats:sub>\n max: 9.99 vs. 6.64\u202fmL\/kg\/min;\n p<\/jats:italic>\n \u202f&lt;\u202f0.001), and sustained till day 91 (1-RM: 15.31 vs. 7.33\u202fkg; VO\n 2<\/jats:sub>\n max: 30.56 vs. 18.14\u202fmL\/kg\/min;\n p<\/jats:italic>\n \u202f&lt;\u202f0.001). In the AshwaSR group, total testosterone levels significantly increased from baseline to day 90 among men (mean increase\u202f=\u202f121.43\u202fng\/dL;\n p<\/jats:italic>\n \u202f=\u202f0.024); while the improvement in testosterone levels among women was non-significant (13.34\u202fng\/dL;\n p<\/jats:italic>\n \u202f=\u202f0.545) and remained within normal reference ranges. The mean changes for total testosterone were similar between AshwaSR and placebo groups (\n p<\/jats:italic>\n \u202f&gt;\u202f0.05). AshwaSR group reported significantly improved quality of life at day 91 compared to placebo group (Mental component: 7.72 vs.\u202f\u2212\u202f4.66;\n p<\/jats:italic>\n \u202f&lt;\u202f0.001; Physical component: 5.23 vs.\u202f\u2212\u202f1.91;\n p<\/jats:italic>\n \u202f&lt;\u202f0.001). Reported adverse events in both groups were mild and transient in nature.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Three-months supplementation with AshwaSR 300\u202fmg\/day was safe and effective in improving muscular strength, cardiorespiratory endurance, and overall wellbeing in recreationally active healthy adults.<\/jats:p>\n <\/jats:sec>\n \n Clinical trial registration<\/jats:title>\n \n CTRI\/2025\/04\/084383,\n https:\/\/ctri.nic.in<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fnut.2026.1919322","type":"journal-article","created":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T06:00:08Z","timestamp":1788933608000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of a sustained release ashwagandha root extract capsules on muscle strength and cardiorespiratory endurance in recreationally active individuals: a randomized, double-blind, placebo-controlled trial"],"prefix":"10.3389","volume":"13","author":[{"given":"Shefali","family":"Thanawala","sequence":"first","affiliation":[{"name":"Medical Science and Research, Nutriventia Private Limited","place":["Mumbai, Maharashtra, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajat","family":"Shah","sequence":"additional","affiliation":[{"name":"Executive Management, Nutriventia Private Limited","place":["Mumbai, Maharashtra, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alphy","family":"Lopes","sequence":"additional","affiliation":[{"name":"Medical Science and Research, Nutriventia Private Limited","place":["Mumbai, Maharashtra, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Girish","family":"Rudrappa","sequence":"additional","affiliation":[{"name":"Orthopedics Department, Rajalakshmi Hospital and Research Center","place":["Bangalore, Karnataka, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prabakaran","family":"Desomayanandam","sequence":"additional","affiliation":[{"name":"Clinical Operations, Invitro Research Solutions Private Limited","place":["Bangalore, Karnataka, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sahitya","family":"Srinivas","sequence":"additional","affiliation":[{"name":"Clinical Operations, Invitro Research Solutions Private Limited","place":["Bangalore, Karnataka, India"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,9]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"a439","DOI":"10.1136\/bmj.a439","article-title":"Association between muscular strength and mortality in men: prospective cohort study","volume":"337","author":"Ruiz","year":"2008","journal-title":"BMJ"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"105792","DOI":"10.1016\/j.jamda.2025.105792","article-title":"Physical fitness, biological aging, and healthy longevity","volume":"26","author":"Chen","year":"2025","journal-title":"J Am Med Dir Assoc"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"497","DOI":"10.1007\/s10522-015-9631-7","article-title":"Live strong and prosper: the importance of skeletal muscle strength for healthy ageing","volume":"17","author":"McLeod","year":"2016","journal-title":"Biogerontology"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1002\/jcsm.12238","article-title":"Skeletal muscle performance and ageing","volume":"9","author":"Tieland","year":"2018","journal-title":"J Cachexia Sarcopenia Muscle"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"1584610","DOI":"10.3389\/fpubh.2025.1584610","article-title":"Association of 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