The Effects of Ashwagandha in Endurance Exercise Performance
Keywords
Abstract
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.
Dates
| Last Verified: | 10/31/2018 |
| First Submitted: | 06/27/2018 |
| Estimated Enrollment Submitted: | 07/19/2018 |
| First Posted: | 07/22/2018 |
| Last Update Submitted: | 11/22/2018 |
| Last Update Posted: | 11/25/2018 |
| Actual Study Start Date: | 08/05/2018 |
| Estimated Primary Completion Date: | 11/30/2018 |
| Estimated Study Completion Date: | 05/31/2019 |
Condition or disease
Intervention/treatment
Dietary Supplement: Ashwagandha extract
Dietary Supplement: Placebo
Phase
Arm Groups
| 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. | |
| Placebo Comparator: Placebo 180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Performance (mean power output (Watt)) [30-min simulated time trials]
Secondary Outcome Measures
1. 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]
2. 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]
3. Oxygen Intake (VO2Max) [Measured during Incremental, 90s, and 30 min time trial.]
