Study Stopped
Lack of Funds
Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance
The Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance in Healthy 18 - 35 Year Olds
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is a single-center, randomized, placebo-controlled pilot study to evaluate the effects of high intensity interval training (HIIT) and daily administration of BasisTM for 3 weeks, in 18-35 year old males. The study will consist of a screening visit, baseline visit, followed by treatment and HIIT phase (3 weeks) and a post-supplementation, follow-up visit (this will occur 48 h (or more) after the final HIIT session). Following the screening phase, subjects who meet entry criteria will be randomly assigned to 1 of 2 treatment groups: recommended dose of BasisTM (250 mg Nicotinamide Riboside and 50 mg Pterostilbene) per day or matching-placebo in a 1:1 ratio.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFebruary 15, 2023
February 1, 2023
2 months
August 6, 2019
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mitochondrial function
Measured via high-resolution respirometry using the Oroboros Oxygraph
3 weeks
Secondary Outcomes (11)
Exercise Capacity
3 weeks
Muscle strength
3 weeks
Muscle power
3 weeks
Mitochondrial proteins
3 weeks
Body Mass
3 weeks
- +6 more secondary outcomes
Study Arms (2)
1X dose of NRPT
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Subjects randomly assigned to the active group will receive Nicotinamide Riboside and Pterostilbene (each capsule contains 125 mg NR and 25 mg PT, total daily dose is 2 capsules) for 3 weeks
Subjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks
Eligibility Criteria
You may qualify if:
- to 35 year old males
- Body mass index between 18.5-30 kg.m-2
- Ability to give informed consent
- Recreationally active (defined in the present study as exercising once a week or more).
You may not qualify if:
- Those regularly conducting HIIT or highly trained in endurance events (e.g. triathlete)
- Currently taking supplements known to affect metabolism (e.g. ibuprofen, stimulants, vitamins, NR)
- Taking prescribed medication
- Consuming a vegan diet
- Consuming a high fat, low carbohydrate diet
- Habitual consumption of protein and/or dairy supplements (e.g. whey protein)
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elysium Healthlead
- University of Exetercollaborator
Study Sites (1)
University of Exeter
Exeter, EX1 2LU, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy Etheridge, PhD
University of Exeter
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 8, 2019
Study Start
February 1, 2023
Primary Completion
April 1, 2023
Study Completion
May 1, 2023
Last Updated
February 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share