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

August 18, 2008
June 18, 2012
June 2007
March 2009   (final data collection date for primary outcome measure)
Fasting insulin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Biomarkers of inflammation and diabetic status [ Time Frame: One month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00737815 on ClinicalTrials.gov Archive Site
Gene Expression [ Time Frame: One month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Crossover Study of Magnesium Supplementation
Magnesium Supplements, Plasma Inflammatory Markers, and Gene Expression in Overweight Individuals With Metabolic Syndrome: a Randomized , Controlled Crossover Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Diabetes Mellitus, Type 2
  • Inflammation
  • Dietary Supplement: Magnesium Citrate: a total of 500 mg elemental magnesium
    500 mg elemental magnesium
  • Other: Placebo
    Inactive placebo pill
  • Active Comparator: A
    Magnesium citrate: a total of 500 mg of elemental magnesium
    Intervention: Dietary Supplement: Magnesium Citrate: a total of 500 mg elemental magnesium
  • Placebo Comparator: B
    Placebo pills
    Intervention: Other: Placebo
Chacko SA, Sul J, Song Y, Li X, LeBlanc J, You Y, Butch A, Liu S. Magnesium supplementation, metabolic and inflammatory markers, and global genomic and proteomic profiling: a randomized, double-blind, controlled, crossover trial in overweight individuals. Am J Clin Nutr. 2011 Feb;93(2):463-73. doi: 10.3945/ajcn.110.002949. Epub 2010 Dec 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00737815
GM-LIU, Award No. 200602222, Fund No. 445963-SM-57277
No
Simin Liu, Dr., University of California, Los Angeles
University of California, Los Angeles
Not Provided
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
University of California, Los Angeles
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP