Randomized controlled trial2023Industry fundedOpen access

Funded in part by Verdure Sciences, verdure sciences

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, Lopresti AL, Fairchild TJ

Journal of psychopharmacology (Oxford, England) · 30 citations

Review labels

Industry funded

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Industry funded
Company
Verdure Sciences
Company
verdure sciences

Based on 2 listed funder(s).

Publication

Published
2023-09-23 · J Psychopharmacol · vol. 37 · issue 11 · pp. 1091–1104
Publisher
SAGE Publishing
Cited
49 citations · more than 99% of similar papers · 15.4× the field average
Impact
Top 10% most cited in its field
References
81 works
Access
Open access (hybrid journal) · CC-BY
Research areas
Phytochemicals and Medicinal Plants · Mindfulness and Compassion Interventions · Multidisciplinary Research Papers Compilation
Keywords
Placebo, Withania somnifera, Medicine, Randomized controlled trial, Perceived Stress Scale, Physical therapy, Placebo-controlled study, Testosterone (patch), Internal medicine, Double blind, Stress (linguistics)
MeSH
humans, withania, obesity, fatigue, plant extracts, double-blind method, adult, female, male, overweight

3 authors

From AU

  • Stephen James Smith · correspondingMurdoch University
  • Adrian L. LoprestiMurdoch University
  • Timothy J. FairchildMurdoch University

Abstract

Background

Stress is a state of homeostasis in the body being challenged, resulting in a systemic response. It has become more prevalent in recent years and affects mental and physical health.

Aims

Evaluate the effects of ashwagandha on stress, fatigue, and sex hormones in overweight or mildly obese men and women with self-reported stress and fatigue.

Methods

Two-arm, parallel-group, 12-week, randomized, double-blind, placebo-controlled trial on overweight or mildly obese men and women aged 40-75 years, supplementing with 200 mg of an ashwagandha root extract (Witholytin®) twice daily.

Results/outcomes

Supplementation with ashwagandha was associated with a significant reduction in stress levels based on the Perceived Stress Scale (primary outcome); however, the improvements were not significantly different to the placebo group (p = 0.867). Based on the Chalder Fatigue Scale, there was a statistically significant reduction in fatigue symptoms in the ashwagandha group compared to the placebo group (p = 0.016), and participants taking ashwagandha also experienced a significant increase in heart rate variability (p = 0.003). However, there were no significant between-group differences in other self-report outcome measures. In the men taking ashwagandha, there was a significant increase in the blood concentrations of free testosterone (p = 0.048) and luteinizing hormone (p = 0.002) compared to the placebo group.

Conclusions/interpretation

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. This may be via its impact on the autonomic nervous system. However, further research is required to expand on these current findings.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).

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