Exploring the efficacy and safety of a novel standardized ashwagandha (Withania somnifera) root extract (Witholytin) in adults experiencing high stress and fatigue in a randomized, double-blind, placebo-controlled trial
Smith SJ, et al
Published in Journal of Psychopharmacology
Methodology
Randomised, double-blind, placebo-controlled parallel trial over 12 weeks in adults reporting high stress and fatigue, using validated fatigue, stress, mood and hormonal endpoints.
Key Findings
In adults with high stress and fatigue, 12 weeks of a standardised ashwagandha root extract (Witholytin) reduced fatigue (primary outcome) significantly more than placebo, but did not significantly improve perceived stress, depression or anxiety scores; testosterone rose modestly in men, and the extract was well tolerated.
Conclusions
The results of this study suggest that in overweight middle-to-older age adults experiencing high stress and fatigue, compared to the placebo, ashwagandha did not have a significantly greater impact on perceived stress levels. However, based on secondary outcome measures, it may have anti-fatigue effects.
Limitations
Moderate sample size and high placebo response; self-reported primary outcome; 12-week duration with no follow-up; the study extract was supplied and part-funded by its manufacturer; secondary endpoints numerous without full multiplicity control.
Supplements Studied
Compared to the placebo, ashwagandha did not have a significantly greater impact on perceived stress levels. However, based on secondary outcome measures, it may have anti-fatigue effects.
Related Health Concerns
Study Details
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Disclosures
Funding
Industry (ashwagandha extract manufacturer) supplied product and part-funded the trial
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