NCT07041853

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

June 19, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

ashwagandhaathleterecoveryperformancecortisol

Outcome Measures

Primary Outcomes (2)

  • Cortisol

    Salivary cortisol

    Baseline and final measurement at 6 weeks

  • Hand grip

    Hand grip strength in kilograms, CAMRY dynanometer

    Baseline and final measurement at 6 weeks

Secondary Outcomes (6)

  • Testosterone

    Baseline and final measurement at 6 weeks

  • Melatonin

    Baseline and final measurement at 6 weeks

  • DHEA-s

    Baseline and final measurement at 6 weeks

  • Alpha-amylase

    Baseline and final measurement at 6 weeks

  • Cortisone

    Baseline and final measurement at 6 weeks

  • +1 more secondary outcomes

Study Arms (2)

KSM-66 Ashwagandha

EXPERIMENTAL

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

Dietary Supplement: KSM-66 Ashwagandha

Placebo

PLACEBO COMPARATOR

600mg organic chickpea flour, once daily taken with dinner

Dietary Supplement: Placebo

Interventions

KSM-66 AshwagandhaDIETARY_SUPPLEMENT

Root extract ashwagandha, KSM-66

KSM-66 Ashwagandha
PlaceboDIETARY_SUPPLEMENT

Organic chickpea flour

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Club Natació Poble Nou

Barcelona, Spain

Location

Related Publications (1)

  • Coope OC, Otaegui E, Suarez M, Levington A, Abad-Sangra M, Lloyd B, Spurr TJ, Roman-Vinas B. Ashwagandha Root Extract Stabilises Physiological Stress Responses in Male and Female Team Sports Athletes During Pre-Season Training. Nutrients. 2026 Jan 12;18(2):230. doi: 10.3390/nu18020230.

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
Professor

Study Record Dates

First Submitted

June 19, 2025

First Posted

June 27, 2025

Study Start

June 12, 2025

Primary Completion

July 31, 2025

Study Completion

August 25, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

IPD will be made available upon reasonable request for academic research purposes.

Shared Documents
ICF

Locations