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Effects of Organic Whole-Food Magnesium (E-Z MgTM) on Mood, Fatigue, Sleep, and Cardiometabolic Outcomes in Adults With Elevated Blood Glucose
Sponsor study identifier
interventional
45
0 countries
N/A
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2026
Actual (reported)October 8, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Subjective Sleep Disturbance
Change in subjective sleep outcomes assessed using the PROMIS Sleep Disturbance and PROMIS Sleep-Related Impairment questionnaires.
Baseline, Week 6, and Week 12
Change in Objective Sleep Measures
Change in objective sleep measures assessed using wrist-worn actigraphy.
Baseline, Week 6, and Week 12
Change in Anxiety Symptoms
Change in anxiety symptoms assessed using the PROMIS Emotional Distress-Anxiety questionnaire.
Baseline, Week 6, and Week 12
Change in Depressive Symptoms
Change in depressive symptoms assessed using the PROMIS Emotional Distress-Depression questionnaire.
Baseline, Week 6, and Week 12
Change in Glycemic Control
Baseline, Week 6, and Week 12.
Change in Insulin Sensitivity/Resistance
Baseline, Week 6, and Week 12.
Change in Continuous Glucose Monitoring Measures
Baseline, Week 6, and Week 12.
Change in Lipid Profile
Baseline, Week 6, and Week 12.
Change in Inflammation
Baseline, Week 6, and Week 12.
Change in Physical Activity
Baseline, Week 6, and Week 12.
Participants will receive E-Z Mg™, providing 70 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education.
Participants will receive E-Z Mg™, providing 140 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education.
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.
First Submitted
September 30, 2026
First Posted
October 8, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
Change in Fatigue
Change in fatigue assessed using the PROMIS Fatigue questionnaire.
Baseline, Week 6, and Week 12
Participants will receive a placebo containing no magnesium for 12 weeks. Participants will also receive standardized nutrition education.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
September 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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