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Randomized Crossover Study of Magnesium Supplementation

Primary Purpose

Diabetes Mellitus, Type 2, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnesium Citrate: a total of 500 mg elemental magnesium
Placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Randomized Controlled Trial, Magnesium, Diabetes Mellitus, Type 2, Inflammation

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Magnesium citrate: a total of 500 mg of elemental magnesium

Placebo pills

Outcomes

Primary Outcome Measures

Fasting insulin

Secondary Outcome Measures

Gene Expression

Full Information

First Posted
August 18, 2008
Last Updated
June 18, 2012
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00737815
Brief Title
Randomized Crossover Study of Magnesium Supplementation
Official Title
Magnesium Supplements, Plasma Inflammatory Markers, and Gene Expression in Overweight Individuals With Metabolic Syndrome: a Randomized , Controlled Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Inflammation
Keywords
Randomized Controlled Trial, Magnesium, Diabetes Mellitus, Type 2, Inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Magnesium citrate: a total of 500 mg of elemental magnesium
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo pills
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium Citrate: a total of 500 mg elemental magnesium
Intervention Description
500 mg elemental magnesium
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive placebo pill
Primary Outcome Measure Information:
Title
Fasting insulin
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Gene Expression
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simin Liu, M.D., Sc.D
Organizational Affiliation
UCLA Program on Genomics and Nutrition
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Sul, M.D.
Organizational Affiliation
UCLA Program on Genomics and Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA General Clinical Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21159786
Citation
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.
Results Reference
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Randomized Crossover Study of Magnesium Supplementation

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