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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

ConditionsStrength Training AdaptationsStressSleep QualityCognitive FunctionsOxidative StressInflammation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age25-40
SponsorGdansk University of Physical Education and Sport

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • Resistance training

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Ashwagandha + resistance trainingExperimental treatment 2 interventions
Group B: Placebo + resistance trainingPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline and 12 weeks.
2

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

Time frame
Baseline to 12 weeks
3

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

Time frame
Baseline to 12 weeks

Secondary outcomes

1

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.

Time frame
Baseline to 12 weeks.
2

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.

Time frame
Baseline to 12 weeks
3

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.

Time frame
Baseline to 12 weeks
4

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

Time frame
Baseline and 12 weeks

Other outcomes

Sponsors and contacts

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Gdansk University of Physical Education and Sport

Lead sponsor

Source ClinicalTrials.gov
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