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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Stress; Oxidative Stress; Sleep Quality; Cognitive Functions; Strength Training Adaptations
• Intervention / Treatment: Dietary supplement: Ashwagandha; Other: Resistance training; Dietary supplement: Placebo

Detailed Description

This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of 12-week supplementation with Ashwagandha (Withania somnifera) extract on a range of physiological, biochemical and psychological outcomes in healthy adult males, experienced in resistance training.

Ashwagandha is an adaptogenic herb commonly used to support stress resilience, sleep quality, hormonal balance and physical performance. Although prior studies suggest promising benefits in these areas, current evidence is limited in scope and often lacks methodological rigor. Specifically, there is a scarcity of research examining Ashwagandha's effects in physically active individuals and in combination with structured exercise programs.

The goal of this study is to assess whether Ashwagandha supplementation enhances physiological adaptations to resistance training and/or improves health markers in trained individuals. Researchers will also examine the underlying mechanisms by evaluating hormone levels, neurotrophic factors, oxidative stress, inflammation and their relationship with performance and well-being outcomes.

A total of 40 healthy male participants will be recruited and randomly assigned to one of two groups:

• Resistance-trained individuals + resistance training + Ashwagandha (n = 20)
• Resistance-trained individuals + resistance training + placebo (n = 20)

All participants will undergo pre- and post-intervention assessments. Participants will follow a structured resistance training program consisting of three weekly sessions for 12 weeks. Those in the intervention group will receive 400 mg/day of Ashwagandha extract (KSM-66, standardized to 5% withanolides), while control group will receive visually identical placebo capsules.

Primary outcome measures include:

Hormonal and biochemical markers: cortisol, testosterone, IGF-1 - Insulin-like Growth Factor 1, BDNF, and oxidative stress markers (e.g., lipid and protein peroxidation).

Neurocognitive and psychological assessments: cognitive performance (VPT, VFT - Verbal Fluency Test, Stroop Test, TMT-A - Trail Making Test, Part A, TMT-B - Trail Making Test, Part B), perceived stress (PSS-10 - Perceived Stress Scale), and sleep quality (PSQI - Pittsburgh Sleep Quality Index), mood (POMS - Profile of Mood States).

Physical performance: maximal strength (one repetition maximum, 1RM bench press, Biodex), muscular endurance (bench press repetitions to failure at 75% 1RM).

Body composition: skeletal muscle mass and body fat percentage measured via bioelectrical impedance (Seca mBCA 555).

Participants will be monitored for compliance via supplement counts and electronic logs. Dietary intake will be tracked weekly using structured food diaries and analyzed with the Fitatu application. One training session a week will be supervised and logged by certified strength and conditioning coaches, another two will be performed by participants themselves and monitored through an electronic log.

Blood samples will be collected at baseline and post-intervention for hormonal, inflammatory, and oxidative stress analysis. Serum and plasma will be stored at -80°C and analyzed using ELISA and spectrophotometry methods.

The study's main hypotheses are as follows:

Ashwagandha supplementation combined with resistance training will improve hormone profiles (increase testosterone, IGF-1, BDNF; decrease cortisol, stress markers) more than placebo conditions.

Ashwagandha will enhance physical performance (increase maximal strength, muscular endurance, skeletal muscle mass; decrease body fat) beyond that of placebo conditions.

Ashwagandha will reduce perceived stress and improve sleep quality and cognitive function.

Positive correlations are expected between improvements in biomarkers (e.g., BDNF, testosterone) and performance and psychological outcomes.

This study addresses several gaps in the current literature by combining objective physiological and psychological measures, investigating potential mechanisms of action such as oxidative stress and inflammation. Unlike previous research, this trial will examine integrated outcomes rather than isolated variables, allowing for a more comprehensive understanding of Ashwagandha's effects.

Participants will be recruited via social media campaigns and corporate outreach events. Safety monitoring will include weekly contact, adherence checks, and documentation of adverse events. Ashwagandha's safety profile is supported by prior studies using comparable doses (400-600 mg/day), which report low incidence of side effects. Nonetheless, participants may withdraw at any time and will be excluded in the event of injury, illness, or withdrawal of consent.

Ethical approval has been granted, and the study is conducted in accordance with the Declaration of Helsinki. The results are expected to contribute to evidence-based recommendations for adaptogenic supplementation in both trained and general populations. The research team includes experts in physiology, sports nutrition, neuropsychology and clinical supplementation research, ensuring a rigorous and interdisciplinary approach.

By examining how Ashwagandha interacts with physical training and how it affects biological, cognitive and psychological outcomes, this project will help define the contexts in which Ashwagandha can be most effectively used. The study's findings may also have implications for stress management, cognitive health, and performance enhancement strategies in health-conscious or physically active populations.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-336
      • Recruiting
      • Gdansk University of Physical Education and Sport
      • Contact: Żaneta Wojdakowska; Phone Number: +48 58 554 71 01; Email: zaneta.wojdakowska@awf.gda.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Minimum 6 months of consistent resistance training experience
• Participation in at least two resistance training sessions per week
• No use of Ashwagandha, adaptogenic supplements, or medications
• No medical contraindications and signed informed consent

Exclusion Criteria:

• History of cardiovascular events, liver disorders, or psychiatric illness
• Medical contraindications for participation
• Use of nicotine products, including e-cigarettes
• BMI > 29.9, to ensure homogeneity in body composition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ashwagandha + resistance training; Resistance trained individuals will be supplemented with Ashwagandha (400mg of extract a day) and will undergo a resistance training program, consisted of 3 workouts a week, for 12 weeks.	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.; Other Names: Withania Somnifera; 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.; Other Names: Strength training
Placebo Comparator: Placebo + resistance training; Resistance trained individuals will be administered a placebo and will undergo a resistance training program, consisted of 3 workouts a week, for 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.; Other Names: Strength training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Maximal strength of upper lower limbs at 12 weeks.	One-repetition maximum (1RM) in the bench press will be assessed using three attempts with progressively increased loads. Units: kilograms (kg)	Baseline and 12 weeks.
Change from Baseline in cortisol levels at 12 weeks	Serum levels of cortisol will be determined using enzyme-linked immunosorbent assay (ELISA) per the manufacturer's instructions. Units: nmol/l	Baseline to 12 weeks
Change from Baseline in BDNF levels at 12 weeks	Serum levels of BDNF will be determined using enzyme-linked immunosorbent assay (ELISA) per the manufacturer's instructions. Units: pg/ml	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in oxidative stress markers at 12 weeks.	Spectrophotometric determination of lipid and protein peroxidation products in plasma will be conducted as markers of oxidative damage.	Baseline to 12 weeks.
Change from Baseline in visuospatial memory at 12 weeks	Participants will undergo neuropsychological Visual Patterns Test (VPT) administered by a licensed psychologist to evaluate visuospatial memory. Score will be evaluated as a total score of correctly remembered patterns.	Baseline to 12 weeks
Change from Baseline in information processing efficiency at 12 weeks	Participants will undergo neuropsychological tests (Trail Making Test Part A and Trail Making Test Part B) administered by a licensed psychologist to evaluate information processing efficiency. Scores will be evaluated as completion time and number of mistakes. Shorter time and less mistakes mean better results.	Baseline to 12 weeks
Change from Baseline in muscular endurance of upper limbs at 12 weeks.	Maximum number of repetitions at 75% 1RM in the bench press until failure will be performed. Units: number of repetitions	Baseline and 12 weeks
Change from Baseline in testostrone levels at 12 weeks	Serum levels of testosterone will be determined using enzyme-linked immunosorbent assay (ELISA) per the manufacturer's instructions. Units: nmol/l	Baseline to 12 weeks
Change from Baseline in subjective sleep quality at 12 weeks.	Participants will fill in a questionnaire Pittsburgh Sleep Quality Index (PSQI). Total scores will be shown on a scale from 0 to 21, with higher scores indicating worse outcomes.	Baseline and 12 weeks
Change from Baseline in perceived stress at 12 weeks.	Participants will fill in a questionnaire Perceived Stress Scale (PSS). Total scores will be shown on a scale from 0 to 40, with higher scores indicating worse outcomes.	Baseline and 12 weeks.
Change from Baseline in mood states at 12 weeks.	Participants will fill in a questionnaire Profile of Mood States (POMS). Total scores will be shown on a Total Mood Disturbance scale from -30 to 200, with higher scores indicating worse outcomes.	Baseline and 12 weeks.
Change from Baseline in Maximal strength of lower limbs at 12 weeks.	Strength will be assesed using the Biodex (Biodex System 4 Pro, NY, USA) with isometric knee extension at 60 degrees of knee extension and knee flexion at 120 degrees of knee extension.	Baseline and 12 weeks.
Change from Baseline in working memory and information processing efficiency at 12 weeks	Participants will undergo neuropsychological Stroop Test administered by a licensed psychologist to evaluate working memory and information processing efficiency. Scores will be evaluated as completion time and number of mistakes. Shorter time and less mistakes mean better results.	Baseline to 12 weeks
Change from Baseline in body fat percentage at 12 weeks.	Body fat percentage will be measured using the Seca mBCA 555 bioimpedance analyzer, which estimates the proportion of fat mass relative to total body weight. Units: percentage (%)	Baseline and 12 weeks
Change from Baseline in lean body mass at 12 weeks.	Lean body mass will be measured using the SECA bioimpedance analyzer, which estimates the proportion of lean body mass to total body weight. Units: kilograms (kg)	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Gdansk University of Physical Education and Sport

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: stress; resistance training; cognitive functions; ashwagandha supplementation
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Pathologic Processes; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Inflammation; Sleep Initiation and Maintenance Disorders; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training; Ashwagandha
• Other Study ID Numbers: AWFiS/2025_6_MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD will be shared.
• IPD Sharing Time Frame: Beginning 3 months after publication with no end date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No