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The Impact of 12-week Ashwagandha Supplementation Induced by Resistance Training on Strength, Levels of Neurotrophic and Stress Response Proteins, Oxidative and Psychological Stress, and Cognitive Function in Physically Active Male Adults

NCT07803068 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-09-03

No results posted yet for this study

Summary

This clinical trial will study the effects of Ashwagandha (Withania somnifera), a natural plant extract, on physical and mental health in adult men. Ashwagandha is known for its potential to reduce stress, support hormonal balance and improve sleep and physical performance. The study will explore how taking Ashwagandha for 12 weeks, with resistance training, affects various health markers such as stress hormones, brain function, muscle strength, body composition, sleep quality, and cognitive abilities.

Participants will be healthy, non-smoking men aged 25-40, with regular resistance training experience. They will be randomly assigned to one of two groups: (1) weight training + Ashwagandha, (2) weight training + placebo. The study is double-blinded, meaning neither participants nor researchers will know who is receiving Ashwagandha or placebo.

Participants will:

* Take Ashwagandha or a placebo every day for 12 weeks
* Train in the gym three times a week

Researchers will assess changes in blood markers (like cortisol, testosterone and BDNF - brain-derived neurotrophic factor), physical performance (muscle strength and endurance), sleep quality, stress perception and cognitive function before and after the 12-week period. The goal is to better understand how Ashwagandha works.

Conditions

  • Strength Training Adaptations
  • Stress
  • Sleep Quality
  • Cognitive Functions
  • Oxidative Stress
  • Inflammation

Interventions

DIETARY_SUPPLEMENT

Ashwagandha

A supplement (Ashwagandha, KSM-66 extract, standardized to 5% withanolides content) will be administered in capsule form. Supplement will be taken once a day - 2 capsules (each 200mg of extract) taken 1 hour before sleep, totalling 400 mg of Ashwagandha (20mg of withanolides) a day. The intervention will last 12 weeks.

DIETARY_SUPPLEMENT

Placebo

A placebo (starch, matched to Ashwagandha regarding color and texture) will be administered in capsule form. Placebo will be taken once a day - 2 capsules a day. The intervention will last 12 weeks.

OTHER

Resistance training

Participants will follow a standardized, structured, and intensity-adjusted resistance training program consisting of three sessions per week (one supervised, two unsupervised). Training will be conducted under the supervision of a certified strength and conditioning coach. All training sessions will be logged and monitored for adherence.

Sponsors & Collaborators

  • Gdansk University of Physical Education and Sport

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803068 on ClinicalTrials.gov