Exercise PerformanceNCT05282693
Ergogenic Properties of Magnesium Supplementation
A study testing ReMag in people with Exercise Performance and Gut -Microbiota, run by Christopher Bell at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance, Gut -Microbiota, Mitochondrial Function
- What is being tested?
- ReMag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, 80523-1582
About this study
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.
Read the 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.
- Being tested
- ReMag, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReMagDietary supplement
Also called Magnesium Chloride
300 mg of ReMag dissolved in lemon flavor liquid
PlaceboDietary supplement
Lemon flavored liquid
| Study group | Role | What they receive |
|---|---|---|
| ReMag | Experimental | Liquid Lemon flavor drink containing 300 mg magnesium chloride (Regmag) consumed twice daily for 9 days Receives: Dietary Supplement: ReMag |
| ReMag Placebo | Placebo comparator | Liquid Lemon flavor drink placebo comparator consumed twice daily for 9 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of completion of time trial to placebo
Amount of time it takes to cycle 10 kilometers
Measured: After 9 days of intervention
Comparison of power output to placebo
Cycling for 30 seconds
Measured: After 9 days of intervention
Comparison of indirect Calorimetry (VO2max) to placebo
During a standard stress test VO2 max will be measured
Measured: After 8 days of intervention
Comparison of lactate threshold to placebo
During a standard stress test lactate threshold will be measured
Measured: After 8 days of intervention
Comparison of Mitochondrial Function to placebo
Assessed via high-resolution mitochondrial respirometry in permeabilized skeletal muscle.
Measured: 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
Measured: 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
Measured: 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
Measured: After 9 days of intervention
Comparison of abundant microbiota to markers in feces to placebo
Assessed via Linear discriminant analysis Effect Size algorithm
Measured: After 9 days of intervention
Comparison Human Granulocyte Macrophage Colony-Stimulating Factor to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interferon gamma to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 1 beta to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 2 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 4 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 5 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 6 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 7 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 8 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 10 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 12 (p70) to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison interleukin 13 to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison Tumor Necrosis Factor alpha to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Comparison High-sensitivity C-reactive protein to placebo
Assessed via 13-plex human T-cell cytokine panel
Measured: After 9 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start17 Dec 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to either placebo for 9-days of the intervention separated by a 3-week washout period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Bell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Bell, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282693
- Sponsor's protocol ID
- 1659
- Status last verified
- May 2024
- First submitted
- 26 Jan 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergogenic Properties of Magnesium Supplementation
- ClinicalTrials.gov ID
- NCT05282693
- Acronym / sponsor ID
- 1659
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either placebo for 9-days of the intervention separated by a 3-week washout period.
| Arm | Type | Receives |
|---|---|---|
| ReMag | Experimental | Dietary Supplement: ReMagLiquid Lemon flavor drink containing 300 mg magnesium chloride (Regmag) consumed twice daily for 9 days |
| ReMag Placebo | Placebo comparator | Dietary Supplement: PlaceboLiquid Lemon flavor drink placebo comparator consumed twice daily for 9 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReMagAlso: Magnesium Chloride300 mg of ReMag dissolved in lemon flavor liquid | Dietary supplement | ReMag |
| PlaceboLemon flavored liquid | Dietary supplement | ReMag Placebo |
Primary outcome
Comparison of completion of time trial to placebo
Time frame: After 9 days of intervention
Amount of time it takes to cycle 10 kilometers
Comparison of power output to placebo
Time frame: After 9 days of intervention
Cycling for 30 seconds
Comparison of indirect Calorimetry (VO2max) to placebo
Time frame: After 8 days of intervention
During a standard stress test VO2 max will be measured
Comparison of lactate threshold to placebo
Time frame: After 8 days of intervention
During a standard stress test lactate threshold will be measured
Comparison of Mitochondrial Function to placebo
Time frame: After 8 days of intervention
Assessed via high-resolution mitochondrial respirometry in permeabilized skeletal muscle.
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
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
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
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
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
Comparison interferon gamma to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 1 beta to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 2 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 4 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 5 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 6 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 7 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 8 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 10 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 12 (p70) to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison interleukin 13 to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison Tumor Necrosis Factor alpha to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Comparison High-sensitivity C-reactive protein to placebo
Time frame: After 9 days of intervention
Assessed via 13-plex human T-cell cytokine panel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReMag in people with Exercise Performance and Gut -Microbiota, run by Christopher Bell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of completion of time trial to placebo (time frame: After 9 days of intervention). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.