JMIR Publications

ABSTRACT

Background:

Academic stress is a major contributor to impaired mental well-being and academic performance among university students. Ashwagandha (Withania somnifera), an Ayurvedic medicinal plant with adaptogenic properties, has been investigated as a potential intervention for stress-related outcomes. However, evidence in otherwise healthy university students remains limited.

Objective:

This study aims to evaluate the effects of an 8-week supplementation regimen with an ashwagandha-containing supplement on perceived stress and related outcomes in healthy university students during the final eight weeks of the academic semester, a period typically characterized by increased academic demands preceding final examinations.

Methods:

This single-center, prospective pilot study employs a single-arm pre–post design and will enroll 35 healthy students from Trier University of Applied Sciences. Participants will receive an ashwagandha-containing multi-ingredient food supplement providing 300 mg/day of standardized Withania somnifera root extract for 8 weeks. The primary outcome is the change in perceived stress from baseline to the end of the 8-week intervention, assessed using the 10-item Perceived Stress Scale (PSS-10). Secondary outcomes include stress and coping assessed using the Stress and Coping Inventory, salivary and urinary cortisol concentrations, urinary epinephrine and norepinephrine concentrations, and nutritional status. Adherence to the supplementation regimen, participant acceptability, and study retention will additionally be assessed. Safety will be evaluated based on participant-reported adverse events. Baseline characteristics, adherence, acceptability, retention, and safety data will be summarized descriptively. Within-participant changes from baseline to the end of the intervention will be analyzed using the Wilcoxon signed-rank test. Ethical approval was obtained on May 20, 2026.

Results:

Participant enrollment commenced on June 1, 2026. A total of 36 participants were enrolled. Data collection is expected to be completed by August 31, 2026, followed by data analysis. Descriptive study results are expected to be available in October 2026.

Conclusions:

This pilot study will provide preliminary estimates of within-participant changes in perceived stress and related psychometric and biochemical stress markers in healthy university students. The findings will provide a basis for refining the study design and informing sample size calculations for a subsequent adequately powered randomized controlled trial.Trial Clinical Trial: German Clinical Trials Register (DRKS), DRKS00040433. Prospectively registered on 22 May 2026.