Ergogenic Properties of Magnesium Supplementation

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: Recruiting
• Conditions: Exercise Performance; Gut -Microbiota; Mitochondrial Function
• Intervention / Treatment: Dietary supplement: ReMag; Dietary supplement: Placebo

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Bell, PhD; Phone Number: 970-491-7522; Email: christopher.bell@colostate.edu
• Study Contact Backup: Name: Laurie Biela; Phone Number: 970-491-2242; Email: Laurie.Biela@colostate.edu

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523-1582
      • Recruiting
      • Colorado State University, Dept. of Health and Exercise Science
      • Contact: Christopher Bell, PhD; Phone Number: 970-491-7522; Email: christopher.bell@colostate.edu
      • Contact: Laurie M Biela, BS; Phone Number: 970-491-2242; Email: Laurie.Biela@colostate.edu
      • Principal Investigator: Christopher Bell, PhD
      • Principal Investigator: Tiffany Weir, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Comparison of completion of time trial to placebo	Amount of time it takes to cycle 10 kilometers	After 9 days of intervention
Comparison of power output to placebo	Cycling for 30 seconds	After 9 days of intervention
Comparison of indirect Calorimetry (VO2max) to placebo	During a standard stress test VO2 max will be measured	After 8 days of intervention
Comparison of lactate threshold to placebo	During a standard stress test lactate threshold will be measured	After 8 days of intervention
Comparison of Mitochondrial Function to placebo	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	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	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	Assessed via 16s ribosomal ribonucleic acid microbial profiling	After 9 days of intervention
Comparison of abundant microbiota to markers in feces to placebo	Assessed via Linear discriminant analysis Effect Size algorithm	After 9 days of intervention
Comparison Human Granulocyte Macrophage Colony-Stimulating Factor to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interferon gamma to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 1 beta to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 2 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 4 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 5 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 6 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 7 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 8 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 10 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 12 (p70) to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison interleukin 13 to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison Tumor Necrosis Factor alpha to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention
Comparison High-sensitivity C-reactive protein to placebo	Assessed via 13-plex human T-cell cytokine panel	After 9 days of intervention

Collaborators and Investigators

• Sponsor: Christopher Bell

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID 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