Ergogenic Properties of Magnesium Supplementation

NCT05282693 | Completed

• 1 other identifier: 1659
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise Performance; Gut -Microbiota; Mitochondrial Function

Outcome Measures

Primary Outcomes (23)

• 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

Study Arms (2)

ReMag

EXPERIMENTAL

Liquid Lemon flavor drink containing 300 mg magnesium chloride (Regmag) consumed twice daily for 9 days

Dietary Supplement: ReMag

ReMag Placebo

PLACEBO COMPARATOR

Liquid Lemon flavor drink placebo comparator consumed twice daily for 9 days.

Dietary Supplement: Placebo

Interventions

ReMag DIETARY_SUPPLEMENT

300 mg of ReMag dissolved in lemon flavor liquid

Also known as: Magnesium Chloride

ReMag

Placebo DIETARY_SUPPLEMENT

Lemon flavored liquid

ReMag Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Bell: lead

Study Sites (1)

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

Location

MeSH Terms

Interventions

Magnesium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Magnesium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Coded bottles
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to either placebo for 9-days of the intervention separated by a 3-week washout period.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 16, 2022
• Study Start: December 17, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)