- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03596307
The Effects of Ashwagandha in Endurance Exercise Performance
The Effects of Ashwagandha In Endurance Exercise Performance
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Heverlee
-
Leuven, Heverlee, Belgium, BE3001
- KU Leuven Athletic Performance Center / Bakala Academy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ashwagandha extract
180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.
|
Shoden 180 mg capsule.
Other Names:
Placebo 180 mg (Sucrose) capsule.
|
Placebo Comparator: Placebo
180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.
|
Shoden 180 mg capsule.
Other Names:
Placebo 180 mg (Sucrose) capsule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance (mean power output (Watt))
Time Frame: 30-min simulated time trials
|
Simulated time trial on cycling ergometer (Avantronic Cyclus2)
|
30-min simulated time trials
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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)
|
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)
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.
|
Measured during Incremental, 90s, and 30 min time trial.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Hespel, Prof, Department of Kinesiology - KU Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AN-07SHO 0518H1-ULE02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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