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Whole-Food Magnesium for Mental and Cardiometabolic Health
Sponsor: George Mason University
Summary
This randomized, double-blind, placebo-controlled clinical trial will evaluate the effects of daily supplementation with E-Z Mg™, a commercially available whole-food-based magnesium supplement, on sleep, mood, fatigue, and cardiometabolic health in adults with elevated blood glucose. The study will enroll 45 adults aged 40-70 years with HbA1c 5.7%-6.4% and BMI 18.5-29.9 kg/m². Participants will be randomized to receive low-dose E-Z Mg™ providing 70 mg elemental magnesium per day, moderate-dose E-Z Mg™ providing 140 mg elemental magnesium per day, or placebo containing no magnesium for 12 weeks. All participants will also receive standardized nutrition education. The primary outcomes are changes in subjective and objective sleep quality, mood, and fatigue. These outcomes will be assessed using PROMIS questionnaires and actigraphy. Secondary outcomes include glycemic control, insulin sensitivity, continuous glucose monitoring-derived glucose measures, lipid profile, liver enzymes, inflammatory markers, blood pressure, anthropometric measures, body composition, dietary intake, and physical activity. Study assessments will occur at baseline, Week 6, and Week 12 and will include fasting blood samples, HbA1c testing (baseline and end of the stuy), continuous glucose monitoring, actigraphy, blood pressure, anthropometric and body composition measurements, dietary and physical activity assessments, demographics and medical and medication history questionnaires, adherence monitoring, and adverse-event monitoring. This study is designed to determine whether whole-food-based magnesium supplementation, and whether different doses of E-Z Mg™, may improve sleep, mood, fatigue, and cardiometabolic outcomes in adults with elevated blood glucose.
Official title: Effects of Organic Whole-Food Magnesium (E-Z MgTM) on Mood, Fatigue, Sleep, and Cardiometabolic Outcomes in Adults With Elevated Blood Glucose
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-11
Completion Date
2027-11
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Low-Dose Whole-Food-Based Magnesium Supplement
Participants assigned to an active intervention arm will receive either 70 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment.
Moderate-Dose Whole-Food-Based Magnesium Supplement
Participants assigned to an active intervention arm will receive either 140 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment.
Placebo
The placebo contains no magnesium and is prepared by the same company as whole food based magnesium. Participants assigned to the placebo arm will take the placebo daily for 12 weeks. The placebo will be provided in identical-looking coded containers to maintain study blinding.