Randomized Crossover Study of Magnesium Supplementation

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT00737815

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jun 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fasting insulin [4 weeks]

Secondary Outcome Measures

Gene Expression [One month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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