The Effects of Ashwagandha in Endurance Exercise Performance

Arjuna Natural

Status: Unknown

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Ashwagandha extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03596307

AN-07SHO 0518H1-ULE02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Ashwagandha extract

Experimental group

Description:

180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Ashwagandha extract

Placebo

Placebo Comparator group

Description:

180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Ashwagandha extract