Randomized Crossover Study of Magnesium Supplementation

June 18, 2012 updated by: Simin Liu, Dr., University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting insulin
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Gene Expression
Time Frame: One month
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (ESTIMATE)

August 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GM-LIU
  • Award No. 200602222
  • Fund No. 445963-SM-57277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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