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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Dietary Supplement: NRPT; Dietary Supplement: Placebo oral capsule

• Registration Number: NCT04050358
• Lead Sponsor: Elysium Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-08
• Status Verified: 2023-02
• Study Start: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15
• Primary Completion: 2023-04
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1X dose of NRPT	NRPT	-
Placebo	Placebo oral capsule	-

Primary Outcome Measures

Name	Time	Method
Mitochondrial function	3 weeks	Measured via high-resolution respirometry using the Oroboros Oxygraph

Secondary Outcome Measures

Name	Time	Method
Physical activity levels using FitBit	3 weeks	To characterize volunteer's habitual physical activity levels.
Exercise Capacity	3 weeks	To measure maximal endurance capacity measured via VO2max
Mitochondrial proteins	3 weeks	To determine whether HIIT with NRPT supplementation improves mitochondrial function more so than HIIT alone, using Western blotting
Body Mass	3 weeks	To determine the effects of HIIT with and without NRPT supplementation on body composition by measuring body mass using a bioelectrical impedance analysis scale
Muscle strength	3 weeks	To measure maximal voluntary contraction using a force transducer strength chair
Muscle power	3 weeks	Determine the effects of HIIT with and without NRPT supplementation on muscle power producing capabilities measured by the 30 second Wingate test
Percent Body Fat	3 weeks	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
Recovery via RESTQ	3 weeks	To determine the effects of HIIT with and without NRPT supplementation on recovery via recovery stress (RESTQ) questionnaire
Blood pressure	3 weeks	Measure blood pressure using Dinamap Pro monitor to characterize demographics of recruited volunteers the recruited volunteers
Recovery via POMS	3 weeks	To determine the effects of HIIT with and without NRPT supplementation on recovery via profile of mood states (POMS)
Height	3 weeks	Measure height using a stadiometer, to characterize demographics of recruited volunteers the recruited volunteers

Trial Locations

Locations (1)

University of Exeter; 🇬🇧 Exeter, United Kingdom