Clinical trial NCT03596307: The Effects of Ashwagandha in Endurance Exercise Performance
Official title: The Effects of Ashwagandha In Endurance Exercise Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Ashwagandha
Endurance
VO2 max
Glycowithanolides
Shoden
Lead sponsor: Arjuna Natural Limited
Sponsor class: INDUSTRY
Collaborators: name: KU Leuven
name: ZB Sports Development BVBA
First posted: 2018-07-23
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Performance (mean power output (Watt))
timeFrame: 30-min simulated time trials
Secondary outcomes:
measure: Rate of perceived exertion
timeFrame: 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
measure: Capillary Lactate
timeFrame: 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
measure: Oxygen Intake (VO2Max)
timeFrame: Measured during Incremental, 90s, and 30 min time trial.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven Athletic Performance Center / Bakala Academy
state: Heverlee
Study officials:
affiliation: Department of Kinesiology - KU Leuven
name: Peter Hespel, Prof
role: PRINCIPAL_INVESTIGATOR
References: