COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Randomized Crossover Study of Magnesium Supplementation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00737815
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):
Simin Liu, Dr., University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Inflammation Dietary Supplement: Magnesium Citrate: a total of 500 mg elemental magnesium Other: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : June 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fasting insulin [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Gene Expression [ Time Frame: One month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737815

Layout table for location information
United States, California
UCLA General Clinical Research Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Layout table for investigator information
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
Publications of Results:
Layout table for additonal information
Responsible Party: Simin Liu, Dr., Director of Genomics and Nutrition, University of California, Los Angeles Identifier: NCT00737815    
Other Study ID Numbers: GM-LIU
Award No. 200602222
Fund No. 445963-SM-57277
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012
Keywords provided by Simin Liu, Dr., University of California, Los Angeles:
Randomized Controlled Trial
Diabetes Mellitus, Type 2
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Magnesium citrate
Gastrointestinal Agents