NCT03596307

Brief Summary

Ashwagandha (Withania Somnifera) is a widely used herb in Ayurvedic medicine for vitality and rejuvenation. This study investigates the effects of both acute and short-term oral supplementation of Shoden (Ashwagandha extract) intake on performance and rate of perceived exertion in high-intensity aerobic and anaerobic exercise.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

June 28, 2018

Last Update Submit

November 23, 2018

Conditions

Healthy

Keywords

AshwagandhaEnduranceVO2 maxGlycowithanolidesShoden

Outcome Measures

Primary Outcomes (1)

  • Performance (mean power output (Watt))

    Simulated time trial on cycling ergometer (Avantronic Cyclus2)

    30-min simulated time trials

Secondary Outcomes (3)

  • Rate of perceived exertion

    At the end of incremental VO2 max test ; halfway (15 min) and at the end (30 min) of the 30 min time trial; on cycling ergometer

  • Capillary Lactate

    Incremental VO2 max test - middle and at the end of each incremental step ; 90s VO2 max test - just before the start of the test and 4 min following exhaustion; 30-Min Time Trial - 5-min intervals

  • Oxygen Intake (VO2Max)

    Measured during Incremental, 90s, and 30 min time trial.

Study Arms (2)

Ashwagandha extract

EXPERIMENTAL

180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

Dietary Supplement: Ashwagandha extractDietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR

180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

Dietary Supplement: Ashwagandha extractDietary Supplement: Placebo

Interventions

Ashwagandha extractDIETARY_SUPPLEMENT

Shoden 180 mg capsule.

Also known as: Shoden, Withania somnifera extract
Ashwagandha extractPlacebo
PlaceboDIETARY_SUPPLEMENT

Placebo 180 mg (Sucrose) capsule.

Ashwagandha extractPlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPhysically fit and involved in physical fitness training, or in individual or team sport activity for 2-4hours per week, or 3-6 hours per week for cycling
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males between 18 and 35 years old
  • Physically fit and involved in physical fitness training, or in individual or team sport activity for 2-4hours per week, or 3-6 hours per week for cycling
  • Body mass index between 18 and 25
  • Good health status confirmed by a medical screening

You may not qualify if:

  • Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise.
  • Intake of any medication or nutritional supplement that is proven to affect exercise performance
  • Intake of analgetics, anti-oxidants, or anti-inflammatory agents from 2 weeks prior to the start of the study
  • More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
  • Blood donation within 3 months prior to the start of the study
  • Smoking
  • Involvement in elite athletic training at a semi-professional or professional level
  • Current participation in another research trial
  • Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven Athletic Performance Center / Bakala Academy

Leuven, Heverlee, BE3001, Belgium

Location

MeSH Terms

Interventions

Ashwagandha

Study Officials

  • Peter Hespel, Prof

    Department of Kinesiology - KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomization 1:1. Acute phase study - Session 1 (2 days) ; Crossover; Session 2 ( 2 Days) Short Term Phase - Session 2 (Pretest), 16 day supplementation, Session 3 (Post test), Crossover; Session 4 (Pretest),16 day supplementation, Session 5 (Post test).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 23, 2018

Study Start

August 6, 2018

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations

BE(1)