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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| ZB Sports Development BVBA | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ashwagandha extract | Experimental | 180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase. |
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| Placebo | Placebo Comparator | 180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ashwagandha extract | Dietary Supplement | Shoden 180 mg capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance (mean power output (Watt)) | Simulated time trial on cycling ergometer (Avantronic Cyclus2) | 30-min simulated time trials |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of perceived exertion | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hespel, Prof | Department of Kinesiology - KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven Athletic Performance Center / Bakala Academy | Leuven | Heverlee | BE3001 | Belgium |
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.
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| ID | Term |
|---|---|
| C030693 | Ashwagandha |
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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).
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Double blinded
| Placebo | Dietary Supplement | Placebo 180 mg (Sucrose) capsule. |
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| Capillary Lactate | 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) | 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. |