Ergogenic Properties of Magnesium Supplementation

May 15, 2024 updated by: Christopher Bell
The purpose of the proposed project is to determine if short-term dietary supplementation of magnesium will improve performance during a series of lab-based exercise tests, will favorably modify the gut-microbiota, and will augment skeletal muscle mitochondrial function.

Study Overview

Status

Status

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

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.

Detailed Description

Magnesium is the fourth most abundant mineral in the human body. It is critical to day-to-day physiological function including the regulation of metabolism, cardiovascular function, immune function, and the operation of the nervous system. In light of its important role in physiology, dietary supplementation of magnesium has been purported to improve athletic performance, although the precise mechanism is unclear. The foci of the proposed study is the ergogenic effects of magnesium, its potential influence on gut health, and its potential ability to improve skeletal muscle function. The investigators will be studying an athletic/competitive population of endurance-trained adults. This group is likely to be the most interested in the use of magnesium to enhance athletic performance. Also, by only recruiting habitual exercisers, the variability between participants is likely to be reduced compared with if the investigators had also recruited people who are usually sedentary.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

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.
  • Not Applicable

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

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523-1582
        • Colorado State University, Dept. of Health and Exercise Science

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Competitive cyclists
  • Adult males and females (18 - 40 years, inclusive) who have exercised a minimum of 5 days per week, for a minimum of 30-minutes/session, during the previous 2 years.
  • Maximal oxygen uptake (VO2max) satisfying the minimum criteria for "Good" (sex- and age-adjusted) as defined by the American College of Sports Medicine.

Exclusion Criteria:

  • Identification of a contra-indication to exercise during a 12-lead exercise stress test
  • Use of a magnesium supplement within the previous 4 weeks
  • Pregnancy or breast-feeding
  • Unable to perform vigorous exercise
  • History (previous diagnosis) of kidney disease
  • Use of laxatives, Zinc, diuretics, proton pump inhibitors, over the counter agents such as certain heartburn and GI/gut treatments (laxatives) which contain magnesium, Zinc or other high dose cations which reduce absorption of Magnesium

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

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.
Experimental: ReMag
Liquid Lemon flavor drink containing 300 mg magnesium chloride (Regmag) consumed twice daily for 9 days
Dietary supplement: ReMag
300 mg of ReMag dissolved in lemon flavor liquid
Other Names:
  • Magnesium Chloride
Placebo Comparator: ReMag Placebo
Liquid Lemon flavor drink placebo comparator consumed twice daily for 9 days.
Dietary supplement: Placebo
Lemon flavored liquid

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
Comparison of completion of time trial to placebo
Time Frame: After 9 days of intervention
Amount of time it takes to cycle 10 kilometers
After 9 days of intervention
Comparison of power output to placebo
Time Frame: After 9 days of intervention
Cycling for 30 seconds
After 9 days of intervention
Comparison of indirect Calorimetry (VO2max) to placebo
Time Frame: After 8 days of intervention
During a standard stress test VO2 max will be measured
After 8 days of intervention
Comparison of lactate threshold to placebo
Time Frame: After 8 days of intervention
During a standard stress test lactate threshold will be measured
After 8 days of intervention
Comparison of Mitochondrial Function to placebo
Time Frame: After 8 days of intervention
Assessed via high-resolution mitochondrial respirometry in permeabilized skeletal muscle.
After 8 days of intervention
Comparison of Shannon and Faith's microbiota diversity scores in feces to placebo
Time Frame: After 9 days of intervention,
Assessed via 16s ribosomal ribonucleic acid microbial profiling
After 9 days of intervention,
Calculation and ordination of B-diversity scores for all fecal samples to assess clustering
Time Frame: After 9 days of intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
After 9 days of intervention
Determination of differentially abundant microbiota in feces of collected during treatment compared to placebo
Time Frame: After 9 days of intervention
Assessed via 16s ribosomal ribonucleic acid microbial profiling
After 9 days of intervention
Comparison of abundant microbiota to markers in feces to placebo
Time Frame: After 9 days of intervention
Assessed via Linear discriminant analysis Effect Size algorithm
After 9 days of intervention
Comparison Human Granulocyte Macrophage Colony-Stimulating Factor to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interferon gamma to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 1 beta to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 2 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 4 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 5 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 6 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 7 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 8 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 10 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 12 (p70) to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison interleukin 13 to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison Tumor Necrosis Factor alpha to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention
Comparison High-sensitivity C-reactive protein to placebo
Time Frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
After 9 days of intervention

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.
Christopher Bell

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 (Actual)

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.
December 17, 2021

Primary Completion (Actual)

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.
February 28, 2024

Study Completion (Actual)

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.
February 28, 2024

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).
January 26, 2022

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.
March 7, 2022

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.
March 16, 2022

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.
May 16, 2024

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.
May 15, 2024

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.
May 1, 2024

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.
  • 1659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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