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

February 13, 2023 updated by: Elysium Health

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mitochondrial function
Time Frame: 3 weeks
Measured via high-resolution respirometry using the Oroboros Oxygraph
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: 3 weeks
To measure maximal endurance capacity measured via VO2max
3 weeks
Muscle strength
Time Frame: 3 weeks
To measure maximal voluntary contraction using a force transducer strength chair
3 weeks
Muscle power
Time Frame: 3 weeks
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
Time Frame: 3 weeks
To determine whether HIIT with NRPT supplementation improves mitochondrial function more so than HIIT alone, using Western blotting
3 weeks
Body Mass
Time Frame: 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
3 weeks
Percent Body Fat
Time Frame: 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
3 weeks
Recovery via POMS
Time Frame: 3 weeks
To determine the effects of HIIT with and without NRPT supplementation on recovery via profile of mood states (POMS)
3 weeks
Recovery via RESTQ
Time Frame: 3 weeks
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
Time Frame: 3 weeks
To characterize volunteer's habitual physical activity levels.
3 weeks
Height
Time Frame: 3 weeks
Measure height using a stadiometer, to characterize demographics of recruited volunteers the recruited volunteers
3 weeks
Blood pressure
Time Frame: 3 weeks
Measure blood pressure using Dinamap Pro monitor to characterize demographics of recruited volunteers the recruited volunteers
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elysium Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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