Randomized Crossover Study of Magnesium Supplementation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Simin Liu, Dr., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00737815
First received: August 18, 2008
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

The investigators recent epidemiologic work in several national surveys and cohorts of men and women have shown that dietary patterns high in plant-based foods and phytochemicals are associated with lower plasma levels of insulin, triglycerides, and C-reactive protein, and reduced risk of type 2 DM and CHD. While the physiologic impact of different foods on serum glucose and insulin is of critical importance, the extent to which specific dietary nutrients can modify insulin resistance is not well understood. Magnesium is a biologically active constituent in whole-grain, green leafy vegetables, and nuts and appears to play an essential role in hundreds of physiologic processes in humans. However, it remains uncertain whether magnesium intake can exert effects on insulin sensitivity and inflammation. Moreover, little is known of the extent to which magnesium intake elicits changes in the expression levels of key genes responsible for glucose homeostasis and systemic inflammation. The ultimate clinical question is whether magnesium supplementation would be clinically effective for the improvement of metabolic disorders in not yet diabetic but high-risk individuals, especially those who are susceptible to insulin resistance. Therefore, as a direct follow up on our previous work in studying the health benefits of plant-based foods such as whole grains, fruits and vegetables, we propose a pilot randomized trial to unravel the metabolic and anti-inflammatory effects of magnesium supplementation versus placebo among overweight individuals with the metabolic syndrome who are particularly prone to the adverse effects of magnesium deficiency. Recent advancements in molecular genetics and genomic technologies have also enabled us to analyze the expression levels of thousands of genes simultaneously in different experimental conditions. The application of high throughput microarray technology in randomized-controlled setting when analyzed with novel statistical methods, will not only help our understanding of nutrient-disease relations, but also afford the investigators the opportunity to gain important insight into the molecular mechanism for complex biological systems of inflammation, insulin resistance, and metabolic abnormalities in response to nutrition intervention.


Condition Intervention
Diabetes Mellitus, Type 2
Inflammation
Dietary Supplement: Magnesium Citrate: a total of 500 mg elemental magnesium
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Magnesium Supplements, Plasma Inflammatory Markers, and Gene Expression in Overweight Individuals With Metabolic Syndrome: a Randomized , Controlled Crossover Trial

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Fasting insulin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gene Expression [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Magnesium citrate: a total of 500 mg of elemental magnesium
Dietary Supplement: Magnesium Citrate: a total of 500 mg elemental magnesium
500 mg elemental magnesium
Placebo Comparator: B
Placebo pills
Other: Placebo
Inactive placebo pill

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight individuals (with a BMI of ≥ 25 kg/m2)
  • Between the ages of 30 and 70 years

Exclusion Criteria:

  • Concurrent documented cardiac, or renal disease as recorded by history of myocardial infarction or abnormal creatinine
  • History of known food allergy and/or dietary restriction
  • Diabetes requiring insulin
  • Pregnancy
  • Diarrhea defined as watery stools more than 3 times a day for more than 3 days
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00737815

Locations
United States, California
UCLA General Clinical Research Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Simin Liu, M.D., Sc.D UCLA Program on Genomics and Nutrition
Principal Investigator: James Sul, M.D. UCLA Program on Genomics and Nutrition
  More Information

Publications:
Responsible Party: Simin Liu, Dr., Director of Genomics and Nutrition, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00737815     History of Changes
Other Study ID Numbers: GM-LIU, Award No. 200602222, Fund No. 445963-SM-57277
Study First Received: August 18, 2008
Last Updated: June 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Randomized Controlled Trial
Magnesium
Diabetes Mellitus, Type 2
Inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Magnesium citrate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014