An interventional study of Low-Dose Whole-Food-Based Magnesium Supplement and Moderate-Dose Whole-Food-Based Magnesium Supplement in Elevated Blood Glucose, sponsored by George Mason University. Not yet recruiting. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by George Mason University · Not applicable, Interventional, and Treatment
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.
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's planned enrollment of 45 is close to the median of 46 across 521 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →George Mason University is the lead sponsor of 42 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive E-Z Mg™, providing 70 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education.
Dietary Supplement: Low-Dose Whole-Food-Based Magnesium Supplement
Participants will receive E-Z Mg™, providing 140 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education.
Dietary Supplement: Moderate-Dose Whole-Food-Based Magnesium Supplement
Participants will receive a placebo containing no magnesium for 12 weeks. Participants will also receive standardized nutrition education.
Other: Placebo
Participants assigned to an active intervention arm will receive either 70 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment.
Participants assigned to an active intervention arm will receive either 140 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment.
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.
Change in Subjective Sleep Disturbance
Change in subjective sleep outcomes assessed using the PROMIS Sleep Disturbance and PROMIS Sleep-Related Impairment questionnaires.
Time frame: Baseline, Week 6, and Week 12
Change in Objective Sleep Measures
Change in objective sleep measures assessed using wrist-worn actigraphy.
Time frame: Baseline, Week 6, and Week 12
Change in Anxiety Symptoms
Change in anxiety symptoms assessed using the PROMIS Emotional Distress-Anxiety questionnaire.
Time frame: Baseline, Week 6, and Week 12
Change in Depressive Symptoms
Change in depressive symptoms assessed using the PROMIS Emotional Distress-Depression questionnaire.
Time frame: Baseline, Week 6, and Week 12
Change in Fatigue
Change in fatigue assessed using the PROMIS Fatigue questionnaire.
Time frame: Baseline, Week 6, and Week 12
Change in Glycemic Control
Glycemic control will be assessed using fasting glucose concentration (mg/dL) measured from fasting blood samples
Time frame: Baseline, Week 6, and Week 12.
Change in Insulin Sensitivity/Resistance
Fasting glucose concentration (mg/dL) and fasting insulin concentration (µU/mL) will be measured from fasting blood samples and used to calculate insulin sensitivity/resistance indices, including HOMA-IR, QUICKI, and SPISE. HOMA-IR, QUICKI, and SPISE are calculated indices and are reported as unitless values. Changes from baseline to Week 12 will be compared across study groups.
Time frame: Baseline, Week 6, and Week 12.
Change in Continuous Glucose Monitoring Measures
Assessed using CGM-derived glucose metrics.
Time frame: Baseline, Week 6, and Week 12.
Change in Lipid Profile
Assessed using fasting lipid measurements.
Time frame: Baseline, Week 6, and Week 12.
Change in Inflammation
Assessed using high-sensitivity C-reactive protein (hs-CRP).
Time frame: Baseline, Week 6, and Week 12.
Change in Liver Enzymes
Assessed using ALT and AST.
Time frame: Baseline, Week 6, and Week 12.
Change in Blood Pressure
Assessed using resting systolic and diastolic blood pressure.
Time frame: Baseline, Week 6, and Week 12.
Change in Anthropometric Measures and Body Composition
Assessed using body weight, BMI, and body composition measurements.
Time frame: Baseline, Week 6, and Week 12.
Change in Dietary Intake
Assessed using dietary intake records.
Time frame: Baseline, Week 6, and Week 12.
Change in Long-Term Glycemic Control
HbA1c (%) measured by finger-stick blood collection. Changes from baseline to Week 12 will be compared across study groups.
Time frame: Baseline, Week 12
Change in Physical Activity
Assessed using physical activity questionnaires.
Time frame: Baseline, Week 6, and Week 12.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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