Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Ashwagandha in Endurance Exercise Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596307
Recruitment Status : Unknown
Verified November 2018 by Arjuna Natural Limited.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborators:
KU Leuven
ZB Sports Development BVBA
Information provided by (Responsible Party):
Arjuna Natural Limited

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 23, 2018
Last Update Posted Date November 26, 2018
Actual Study Start Date  ICMJE August 6, 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Performance (mean power output (Watt)) [ Time Frame: 30-min simulated time trials ]
Simulated time trial on cycling ergometer (Avantronic Cyclus2)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Rate of perceived exertion [ Time Frame: 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 ]
    15-point Borg rating scale of perceived exertion (ranging from 6 to 20, where 6 means "no exertion at all",13-14 means "somewhat hard" and 20 means "maximal exertion".). A number is chosen from the scale by an individual that best describes their level of exertion during physical activity.
  • Capillary Lactate [ Time Frame: 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 ]
    Blood samples from earlobes (Lactate Pro1, Arkray, Japan)
  • Oxygen Intake (VO2Max) [ Time Frame: Measured during Incremental, 90s, and 30 min time trial. ]
    Highest oxygen uptake rate measured over a 30-s time-interval at the end of the test.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Ashwagandha in Endurance Exercise Performance
Official Title  ICMJE The Effects of Ashwagandha In Endurance Exercise Performance
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.
Detailed Description

Only a few clinical trials have looked at the effects of Ashwagandha in exercise and training. The studies had a dosage of 2 x 300 mg & 2 x 500 mg per day for 8 weeks and found to stimulate effects of strength training on muscle strength and muscle mass (Wankhede et al., 2015) and small increments in time to exhaustion and VO2max (Shenoy et al., 2012). However, the training intervention in both the studies were not adequately controlled and did not make a distinction between the acute and short-term effects of Ashwagandha intake.

Moreover, a lot of herbal supplements are commercially available containing majority of alkaloids and small amount of withaferine. European Food Safety Authority (EFSA) has categorized anaferine, anahygrine, withanine, sominiferine, somnine, tropine etc as toxic and harmful. Apart from alkaloids, withaferine A has also been categorized as cytotoxic lactones by EFSA. The Ashwagandha extract developed by Arjuna Natural Ltd is free from these alkaloids and is standardized to contain about 35% glycowithanolides.

This study will be a randomized, double blinded, placebo controlled, two treatment, crossover study and will be conducted in 2 phases ( acute & short term) with a total of 5 identical test sessions. Each test session involves a maximal incremental cycling test followed by a 90-sec maximal cycling performance test (day 1), and a 30-min simulated time-triaI on a cycling ergometer (day 2). Day 1 and day 2 are separated by a 24hr rest interval and for each subject it will be consistently scheduled on the same time of the day in order to eliminate a potential impact of diurnal variation in the results.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
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).
Masking: Double (Participant, Investigator)
Masking Description:
Double blinded
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Ashwagandha extract
    Shoden 180 mg capsule.
    Other Names:
    • Shoden
    • Withania somnifera extract
  • Dietary Supplement: Placebo
    Placebo 180 mg (Sucrose) capsule.
Study Arms  ICMJE
  • Experimental: Ashwagandha extract
    180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.
    Interventions:
    • Dietary Supplement: Ashwagandha extract
    • Dietary Supplement: Placebo
  • Placebo Comparator: Placebo
    180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.
    Interventions:
    • Dietary Supplement: Ashwagandha extract
    • Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 20, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: 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
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03596307
Other Study ID Numbers  ICMJE AN-07SHO 0518H1-ULE02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Data sharing can be carried out through a proper research proposal to the scientific review board of Arjuna Natural Ltd except in cases where Arjuna Natural Ltd. has no legal authority because the product has been out-licensed to another company or there is no feasible means to anonymise the data and redact personally identifiable information without compromising the privacy and confidentiality of research participants.
Responsible Party Arjuna Natural Limited
Study Sponsor  ICMJE Arjuna Natural Limited
Collaborators  ICMJE
  • KU Leuven
  • ZB Sports Development BVBA
Investigators  ICMJE
Principal Investigator: Peter Hespel, Prof Department of Kinesiology - KU Leuven
PRS Account Arjuna Natural Limited
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP