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

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 Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: NRPT; Dietary supplement: Placebo oral capsule

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Exeter, United Kingdom, EX1 2LU
    • University of Exeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo oral capsule; Subjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks
Active Comparator: 1X dose of NRPT	Dietary supplement: 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; Other Names: BasisTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitochondrial function	Measured via high-resolution respirometry using the Oroboros Oxygraph	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	To measure maximal endurance capacity measured via VO2max	3 weeks
Muscle strength	To measure maximal voluntary contraction using a force transducer strength chair	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	3 weeks
Mitochondrial proteins	To determine whether HIIT with NRPT supplementation improves mitochondrial function more so than HIIT alone, using Western blotting	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	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	3 weeks
Recovery via POMS	To determine the effects of HIIT with and without NRPT supplementation on recovery via profile of mood states (POMS)	3 weeks
Recovery via RESTQ	To determine the effects of HIIT with and without NRPT supplementation on recovery via recovery stress (RESTQ) questionnaire	3 weeks
Physical activity levels using FitBit	To characterize volunteer's habitual physical activity levels.	3 weeks
Height	Measure height using a stadiometer, to characterize demographics of recruited volunteers the recruited volunteers	3 weeks
Blood pressure	Measure blood pressure using Dinamap Pro monitor to characterize demographics of recruited volunteers the recruited volunteers	3 weeks

Collaborators and Investigators

• Sponsor: Elysium Health
• Collaborators: University of Exeter

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Basis-HIIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes