Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance

NCT ID: NCT04050358

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1X dose of NRPT

Group Type ACTIVE_COMPARATOR

NRPT

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DIETARY_SUPPLEMENT

Subjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks

Interventions

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NRPT

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

Intervention Type DIETARY_SUPPLEMENT

Placebo oral capsule

Subjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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BasisTM

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Exeter

OTHER

Sponsor Role collaborator

Elysium Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Etheridge, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

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University of Exeter

Exeter, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Basis-HIIT

Identifier Type: -

Identifier Source: org_study_id

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