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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05282693
Other study ID # 1659
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2021
Est. completion date February 28, 2024

Study information

Verified date May 2024
Source Colorado State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
ReMag
300 mg of ReMag dissolved in lemon flavor liquid
Placebo
Lemon flavored liquid

Locations

Country Name City State
United States Colorado State University, Dept. of Health and Exercise Science Fort Collins Colorado

Sponsors (1)

Lead Sponsor Collaborator
Christopher Bell

Country where clinical trial is conducted

United States, 

Outcome

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