HealthyPhase 1NCT04050358
Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance
A Phase 1 study testing NRPT in people with Healthy, run by Elysium Health at 1 site in United Kingdom.
Trial 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. 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?
- NRPT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2023to May 2023
- Phase
- Phase 1
- 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
- 18 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance in Healthy 18 - 35 Year Olds
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.
- Conditions
- Healthy
- Being tested
- NRPT, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRPTDietary supplement
Also called BasisTM
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
Placebo oral capsuleDietary supplement
Subjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1X dose of NRPT | Active comparator | Not described Receives: Dietary Supplement: NRPT |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function
Measured via high-resolution respirometry using the Oroboros Oxygraph
Measured: 3 weeks
Secondary outcomes (11)
Exercise Capacity
To measure maximal endurance capacity measured via VO2max
Measured: 3 weeks
Muscle strength
To measure maximal voluntary contraction using a force transducer strength chair
Measured: 3 weeks
Muscle power
Determine the effects of HIIT with and without NRPT supplementation on muscle power producing capabilities measured by the 30 second Wingate test
Measured: 3 weeks
Mitochondrial proteins
To determine whether HIIT with NRPT supplementation improves mitochondrial function more so than HIIT alone, using Western blotting
Measured: 3 weeks
Body Mass
To determine the effects of HIIT with and without NRPT supplementation on body composition by measuring body mass using a bioelectrical impedance analysis scale
Measured: 3 weeks
Percent Body Fat
To determine the effects of HIIT with and without NRPT supplementation on body composition by measuring percent body fat using a bioelectrical impedance analysis scale
Measured: 3 weeks
Recovery via POMS
To determine the effects of HIIT with and without NRPT supplementation on recovery via profile of mood states (POMS)
Measured: 3 weeks
Recovery via RESTQ
To determine the effects of HIIT with and without NRPT supplementation on recovery via recovery stress (RESTQ) questionnaire
Measured: 3 weeks
Physical activity levels using FitBit
To characterize volunteer's habitual physical activity levels.
Measured: 3 weeks
Height
Measure height using a stadiometer, to characterize demographics of recruited volunteers the recruited volunteers
Measured: 3 weeks
Blood pressure
Measure blood pressure using Dinamap Pro monitor to characterize demographics of recruited volunteers the recruited volunteers
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study startFeb 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Lack of Funds
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elysium Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
- Investigators
- Timothy Etheridge, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050358
- Sponsor's protocol ID
- Basis-HIIT
- Status last verified
- Feb 2023
- First submitted
- 6 Aug 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance in Healthy 18 - 35 Year Olds
- ClinicalTrials.gov ID
- NCT04050358
- Acronym / sponsor ID
- Basis-HIIT
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Elysium HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of Exeter
- Study start
- Feb 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 8 Aug 2019 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1X dose of NRPT | Active comparator | Dietary Supplement: NRPT |
| Placebo | Placebo comparator | Dietary Supplement: Placebo oral capsule |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 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).
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| NRPTAlso: BasisTMSubjects 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 | Dietary supplement | 1X dose of NRPT |
| Placebo oral capsuleSubjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks | Dietary supplement | Placebo |
Primary outcome
Mitochondrial function
Time frame: 3 weeks
Measured via high-resolution respirometry using the Oroboros Oxygraph
11 secondary outcomes
Exercise Capacity
Time frame: 3 weeks
Muscle strength
Time frame: 3 weeks
Muscle power
Time frame: 3 weeks
Mitochondrial proteins
Time frame: 3 weeks
Body Mass
Time frame: 3 weeks
Percent Body Fat
Time frame: 3 weeks
Recovery via POMS
Time frame: 3 weeks
Recovery via RESTQ
Time frame: 3 weeks
Physical activity levels using FitBit
Time frame: 3 weeks
Height
Time frame: 3 weeks
Blood pressure
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Timothy Etheridge, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NRPT in people with Healthy, run by Elysium Health at 1 site in United Kingdom.
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 7 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: withdrawn, as of the sponsor's last update on 15 Feb 2023. 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mitochondrial function (time frame: 3 weeks). 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 15 Feb 2023.