Ergogenic Properties of Magnesium Supplementation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ergogenic Properties of Magnesium Supplementation

Conditions
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Exercise Performance, Gut -Microbiota, Mitochondrial Function

Intervention / Treatment
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* Dietary Supplement: ReMag
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to either placebo for 9-days of the intervention separated by a 3-week washout period.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReMag<br>Liquid Lemon flavor drink containing 300 mg magnesium chloride (Regmag) consumed twice daily for 9 days | Dietary Supplement: ReMag<br>* 300 mg of ReMag dissolved in lemon flavor liquid<br>* Other names: Magnesium Chloride;|
| Placebo Comparator: ReMag Placebo<br>Liquid Lemon flavor drink placebo comparator consumed twice daily for 9 days. | Dietary Supplement: Placebo<br>* Lemon flavored liquid<br>|

What is the study measuring?
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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 |