HealthyNCT03596307
The Effects of Ashwagandha in Endurance Exercise Performance
A study testing Ashwagandha extract in people with Healthy, run by Arjuna Natural Limited at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ashwagandha extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Aug 2018to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Belgium1 site
KU Leuven Athletic Performance Center / Bakala Academy
Leuven, Heverlee, BE3001
About this study
Official title: The Effects of Ashwagandha In Endurance Exercise Performance
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ashwagandha extract, Placebo
- Keywords
- Ashwagandha, Endurance, VO2 max, Glycowithanolides, Shoden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ashwagandha extractDietary supplement
Also called Shoden, Withania somnifera extract
Shoden 180 mg capsule.
PlaceboDietary supplement
Placebo 180 mg (Sucrose) capsule.
| Study group | Role | What they receive |
|---|---|---|
| Ashwagandha extract | Experimental | 180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase. Receives: Dietary Supplement: Ashwagandha extract; Dietary Supplement: Placebo |
| Placebo | Placebo comparator | 180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase. Receives: Dietary Supplement: Ashwagandha extract; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance (mean power output (Watt))
Simulated time trial on cycling ergometer (Avantronic Cyclus2)
Measured: 30-min simulated time trials
Secondary outcomes (3)
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.
Measured: 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
Blood samples from earlobes (Lactate Pro1, Arkray, Japan)
Measured: 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: Measured during Incremental, 90s, and 30 min time trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start6 Aug 2018
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arjuna Natural Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KU Leuven, ZB Sports Development BVBA
- Responsible party
- Sponsor
- Investigators
- Peter Hespel, Prof, Principal investigator, Department of Kinesiology - KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596307
- Sponsor's protocol ID
- AN-07SHO 0518H1-ULE02
- Status last verified
- Nov 2018
- First submitted
- 28 Jun 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ashwagandha In Endurance Exercise Performance
- ClinicalTrials.gov ID
- NCT03596307
- Acronym / sponsor ID
- AN-07SHO 0518H1-ULE02
- Conditions
- Healthy
- Keywords
- Ashwagandha, Endurance, VO2 max, Glycowithanolides, Shoden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Arjuna Natural LimitedIndustry (pharma, biotech, devices)
- Collaborators
- KU Leuven, ZB Sports Development BVBA
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Ashwagandha extract | Experimental | Dietary Supplement: Ashwagandha extract, Dietary Supplement: Placebo180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase. |
| Placebo | Placebo comparator | Dietary Supplement: Ashwagandha extract, Dietary Supplement: Placebo180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ashwagandha extractAlso: Shoden, Withania somnifera extractShoden 180 mg capsule. | Dietary supplement | Ashwagandha extract, Placebo |
| PlaceboPlacebo 180 mg (Sucrose) capsule. | Dietary supplement | Ashwagandha extract, Placebo |
Primary outcome
Performance (mean power output (Watt))
Time frame: 30-min simulated time trials
Simulated time trial on cycling ergometer (Avantronic Cyclus2)
3 secondary outcomes
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
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
Oxygen Intake (VO2Max)
Time frame: Measured during Incremental, 90s, and 30 min time trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Hespel, Prof principal investigator
Department of Kinesiology - KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ashwagandha extract in people with Healthy, run by Arjuna Natural Limited at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (mean power output (Watt)) (time frame: 30-min simulated time trials). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.