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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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