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 | Recruiting

• 1 other identifier: AWFiS/2025_6_MS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ashwagandha supplementation; resistance training; cognitive functions; stress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Change from Baseline in oxidative stress markers at 12 weeks.

  Baseline to 12 weeks.

• Change from Baseline in visuospatial memory at 12 weeks

  Baseline to 12 weeks

• Change from Baseline in information processing efficiency at 12 weeks

  Baseline to 12 weeks

• Change from Baseline in muscular endurance of upper limbs at 12 weeks.

  Baseline and 12 weeks

• Change from Baseline in testostrone levels at 12 weeks

  Baseline to 12 weeks

Study Arms (2)

Ashwagandha + resistance training

EXPERIMENTAL

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; Other: Resistance training

Placebo + resistance training

PLACEBO COMPARATOR

Resistance trained individuals will be administered a placebo and will undergo a resistance training program, consisted of 3 workouts a week, for 12 weeks.

Dietary Supplement: Placebo; Other: Resistance training

Interventions

Ashwagandha DIETARY_SUPPLEMENT

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.

Also known as: Withania Somnifera

Ashwagandha + resistance training

Placebo DIETARY_SUPPLEMENT

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.

Placebo + resistance training

Resistance training OTHER

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.

Also known as: Strength training

Ashwagandha + resistance training; Placebo + resistance training

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Inflammation

Interventions

Ashwagandha; Resistance Training

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PhD student

Model Details: The study will be randomized, double-blind, and placebo-controlled.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months after publication with no end date.

Locations

PL (1)