The Effects of KSM-66 Ashwagandha Supplementation on Recovery and Muscle Strength in Academy Athletes

NCT ID: NCT07041853

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2025-08-25

Brief Summary

This double-blind, randomised, placebo-controlled trial will examine the effects of 42-day root extract ashwagandha (KSM-66) supplementation on recovery and muscle strength in male and female rugby and water polo players. Participants will receive either 600 mg of ashwagandha or a placebo daily. Outcomes include hormonal stress markers, perceived exertion, wellness, muscle soreness and strength and performance metrics (grip strength, jump tests, 1RM lifts, Bronco test).

Detailed Description

This double-blind, randomised, placebo-controlled trial aims to investigate the effects of ashwagandha (ASH) supplementation on recovery and muscle strength in male and female rugby and water polo players. Participants will supplement either KSM-66 ashwagandha (600 mg, standardised to 5% withanolides) or a placebo once daily for 42 days. The study will evaluate outcomes related to hormonal stress markers, perceived exertion, wellness, muscle soreness, and physical performance.

Primary biomarkers include cortisol, DHEA-S, testosterone, melatonin, alpha-amylase, and cortisone, assessed through saliva samples. Subjective measures will include the Borg Rate of Perceived Exertion Scale and the Hooper Index for sleep quality, stress, fatigue, and delayed onset muscle soreness (DOMS). Physical performance will be assessed using grip strength (CAMRY dynamometer), vertical jump tests (countermovement jump, squat jump), broad jump, 1-repetition maximum (1RM) tests for deadlift, bench press, and pull-up, as well as the Bronco test. Supplement satisfaction will be evaluated via questionnaire.

Participants' dietary intake will be recorded using a self-tracking method (Snap-N-Send) and analysed using Nutritics software; food diaries will serve as covariates in the final analysis. The study will be conducted in partnership with CN Poble Nou, a professional sports club in Barcelona, Spain.

Ashwagandha use is increasingly common among athletes despite limited evidence on appropriate dosing and performance outcomes. This study will contribute to scientific understanding of its potential short-term benefits, particularly in high-contact sports where managing cortisol and recovery is critical.

All participants will provide informed consent, and ethical considerations focus on safety, data privacy, and the right to withdraw from the study at any time.

Conditions

Recovery; Strength; Exercise Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

KSM-66 Ashwagandha

600mg root extract KSM-66 Ashwagandha, once daily taken with dinner

Group Type: EXPERIMENTAL

KSM-66 Ashwagandha

Intervention Type: DIETARY_SUPPLEMENT

Root extract ashwagandha, KSM-66

Placebo

600mg organic chickpea flour, once daily taken with dinner

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Organic chickpea flour

Interventions

KSM-66 Ashwagandha

Root extract ashwagandha, KSM-66

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Organic chickpea flour

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Above the age of 18
• Healthy and free of disease
• Assigned as an athlete at CN Poble Nou sports academy

Exclusion Criteria

• Allergies to nightshades such as tomato, aubergine, potatoes and peppers
• Active supplementation with other ergogenic aids (to not interfere with existing treatment)
• Medication or contraceptives (to not interfere with existing treatment)
• Liver conditions (to not interfere with existing treatment)
• Thyroid conditions (to not interfere with existing treatment)
• Diabetes or certain autoimmune conditions (to not interfere with existing treatment)
• Active pregnancy (to not interfere with existing treatment)
• No signing of the consent form

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ramon Llull

OTHER

Sponsor Role: lead

Responsible Party

Blanca Roman-Viñas, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Club Natació Poble Nou

Barcelona, , Spain

Countries

Spain

Other Identifiers

05-03-2025

Identifier Type: -

Identifier Source: org_study_id