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Completed

NCT Number: NCT05282693

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.

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Key information

Conditions

Exercise Performance Gut -Microbiota Mitochondrial Function

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReMag

Dietary Supplement

300 mg of ReMag dissolved in lemon flavor liquid

Other names: Magnesium Chloride

Placebo

Dietary Supplement

Lemon flavored liquid

Primary outcomes

  1. Comparison of completion of time trial to placebo

    Time frame: After 9 days of intervention

    Amount of time it takes to cycle 10 kilometers

  2. Comparison of power output to placebo

    Time frame: After 9 days of intervention

    Cycling for 30 seconds

  3. Comparison of indirect Calorimetry (VO2max) to placebo

    Time frame: After 8 days of intervention

    During a standard stress test VO2 max will be measured

  4. Comparison of lactate threshold to placebo

    Time frame: After 8 days of intervention

    During a standard stress test lactate threshold will be measured

  5. Comparison of Mitochondrial Function to placebo

    Time frame: After 8 days of intervention

    Assessed via high-resolution mitochondrial respirometry in permeabilized skeletal muscle.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Comparison interferon gamma to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  12. Comparison interleukin 1 beta to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  13. Comparison interleukin 2 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  14. Comparison interleukin 4 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  15. Comparison interleukin 5 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  16. Comparison interleukin 6 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  17. Comparison interleukin 7 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  18. Comparison interleukin 8 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  19. Comparison interleukin 10 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  20. Comparison interleukin 12 (p70) to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  21. Comparison interleukin 13 to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  22. Comparison Tumor Necrosis Factor alpha to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

  23. Comparison High-sensitivity C-reactive protein to placebo

    Time frame: After 9 days of intervention

    Assessed via 13-plex human T-cell cytokine panel

Sponsors and collaborators

Lead sponsor

Christopher Bell

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2022
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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