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

Healthy Clinical Trial

Official title:

The Effect of Basis™ and High Intensity Interval Training (HIIT) on Muscle Metabolism and Exercise Performance in Healthy 18 - 35 Year Olds

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04050358
• Other study ID #: Basis-HIIT
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 2023
• Est. completion date: May 2023

Study information

• Verified date: February 2023
• Source: Elysium Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter

Sponsors (2)

Lead Sponsor	Collaborator
Elysium Health	University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

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