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
3 other identifiers
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 18, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJune 19, 2012
June 1, 2012
1.8 years
August 18, 2008
June 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting insulin
4 weeks
Secondary Outcomes (1)
Gene Expression
One month
Study Arms (2)
A
ACTIVE COMPARATORMagnesium citrate: a total of 500 mg of elemental magnesium
B
PLACEBO COMPARATORPlacebo pills
Interventions
500 mg elemental magnesium
Eligibility Criteria
You may qualify if:
- Overweight individuals (with a BMI of ≥ 25 kg/m2)
- Between the ages of 30 and 70 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA General Clinical Research Center
Los Angeles, California, 90095, United States
Related Publications (1)
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.
PMID: 21159786RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Genomics and Nutrition
Study Record Dates
First Submitted
August 18, 2008
First Posted
August 20, 2008
Study Start
June 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
June 19, 2012
Record last verified: 2012-06