Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-04 @ 11:42 PM
Study NCT ID:
NCT05282693
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ergogenic Properties of Magnesium Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015636', 'term': 'Magnesium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Coded bottles'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be randomized to either placebo for 9-days of the intervention separated by a 3-week washout period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2022-01-26', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of completion of time trial to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Amount of time it takes to cycle 10 kilometers'}, {'measure': 'Comparison of power output to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Cycling for 30 seconds'}, {'measure': 'Comparison of indirect Calorimetry (VO2max) to placebo', 'timeFrame': 'After 8 days of intervention', 'description': 'During a standard stress test VO2 max will be measured'}, {'measure': 'Comparison of lactate threshold to placebo', 'timeFrame': 'After 8 days of intervention', 'description': 'During a standard stress test lactate threshold will be measured'}, {'measure': 'Comparison of Mitochondrial Function to placebo', 'timeFrame': 'After 8 days of intervention', 'description': 'Assessed via high-resolution mitochondrial respirometry in permeabilized skeletal muscle.'}, {'measure': "Comparison of Shannon and Faith's microbiota diversity scores in feces to placebo", 'timeFrame': 'After 9 days of intervention,', 'description': 'Assessed via 16s ribosomal ribonucleic acid microbial profiling'}, {'measure': 'Calculation and ordination of B-diversity scores for all fecal samples to assess clustering', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 16s ribosomal ribonucleic acid microbial profiling'}, {'measure': 'Determination of differentially abundant microbiota in feces of collected during treatment compared to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 16s ribosomal ribonucleic acid microbial profiling'}, {'measure': 'Comparison of abundant microbiota to markers in feces to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via Linear discriminant analysis Effect Size algorithm'}, {'measure': 'Comparison Human Granulocyte Macrophage Colony-Stimulating Factor to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interferon gamma to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 1 beta to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 2 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 4 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 5 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 6 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 7 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 8 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 10 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 12 (p70) to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison interleukin 13 to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison Tumor Necrosis Factor alpha to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}, {'measure': 'Comparison High-sensitivity C-reactive protein to placebo', 'timeFrame': 'After 9 days of intervention', 'description': 'Assessed via 13-plex human T-cell cytokine panel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Performance', 'Gut -Microbiota', 'Mitochondrial Function']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Competitive cyclists\n* 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.\n* Maximal oxygen uptake (VO2max) satisfying the minimum criteria for "Good" (sex- and age-adjusted) as defined by the American College of Sports Medicine.\n\nExclusion Criteria:\n\n* Identification of a contra-indication to exercise during a 12-lead exercise stress test\n* Use of a magnesium supplement within the previous 4 weeks\n* Pregnancy or breast-feeding\n* Unable to perform vigorous exercise\n* History (previous diagnosis) of kidney disease\n* 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'}, 'identificationModule': {'nctId': 'NCT05282693', 'briefTitle': 'Ergogenic Properties of Magnesium Supplementation', 'organization': {'class': 'OTHER', 'fullName': 'Colorado State University'}, 'officialTitle': 'Ergogenic Properties of Magnesium Supplementation', 'orgStudyIdInfo': {'id': '1659'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReMag', 'description': 'Liquid Lemon flavor drink containing 300 mg magnesium chloride (Regmag) consumed twice daily for 9 days', 'interventionNames': ['Dietary Supplement: ReMag']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ReMag Placebo', 'description': 'Liquid Lemon flavor drink placebo comparator consumed twice daily for 9 days.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'ReMag', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Magnesium Chloride'], 'description': '300 mg of ReMag dissolved in lemon flavor liquid', 'armGroupLabels': ['ReMag']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lemon flavored liquid', 'armGroupLabels': ['ReMag Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80523-1582', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado State University, Dept. of Health and Exercise Science', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christopher Bell', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christopher Bell', 'investigatorAffiliation': 'Colorado State University'}}}}