No phaseNot yet recruiting
Whole-Food Magnesium for Mental and Cardiometabolic Health
Effects of Organic Whole-Food Magnesium (E-Z MgTM) on Mood, Fatigue, Sleep, and Cardiometabolic Outcomes in Adults With Elevated Blood Glucose
- Sponsor
- George Mason University (Academic or other)
- Enrolment
- 45 planned
- Conditions
- Elevated Blood Glucose
- Interventions
- Low-Dose Whole-Food-Based Magnesium Supplement; Moderate-Dose Whole-Food-Based Magnesium Supplement; Placebo
- Ages
- adults, older adults
- Registry
- NCT07865351
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Change in Subjective Sleep Disturbance
- Change in Objective Sleep Measures
- Change in Anxiety Symptoms
- Change in Depressive Symptoms
History
Study completion expected
Primary completion expected
Expected to start
Registered