Whole-Food Magnesium for Mental and Cardiometabolic Health
ConditionElevated Blood Glucose
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorGeorge Mason University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40-70 years
BMI 18.5-29.9 kg/m²
HbA1c 5.7%-6.4%
Stable medication regimen for at least 3 months
Disqualifiers
Severe psychiatric or sleep disorders
Diagnosed diabetes
Pregnancy or breastfeeding
Clinically significant thyroid, kidney, liver, or pancreatic disease
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Dose Whole-Food-Based Magnesium Supplement
Dietary supplementParticipants 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
Dietary supplementParticipants assigned to an active intervention arm will receive either 140 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment.
Placebo
Other interventionThe 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Low-Dose Whole-Food-Based Magnesium SupplementExperimental treatment 1 intervention
Group B: Moderate-Dose Whole-Food-Based Magnesium Supplement PlaceboExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 122
Change in Objective Sleep Measures
Change in objective sleep measures assessed using wrist-worn actigraphy.
Time frame
Baseline, Week 6, and Week 123
Change in Anxiety Symptoms
Change in anxiety symptoms assessed using the PROMIS Emotional Distress-Anxiety questionnaire.
Time frame
Baseline, Week 6, and Week 124
Change in Depressive Symptoms
Change in depressive symptoms assessed using the PROMIS Emotional Distress-Depression questionnaire.
Time frame
Baseline, Week 6, and Week 12Secondary outcomes
1
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 12.2
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 12.3
Change in Continuous Glucose Monitoring Measures
Assessed using CGM-derived glucose metrics.
Time frame
Baseline, Week 6, and Week 12.4
Change in Lipid Profile
Assessed using fasting lipid measurements.
Time frame
Baseline, Week 6, and Week 12.Other outcomes
1
Change in Physical Activity
Assessed using physical activity questionnaires.
Time frame
Baseline, Week 6, and Week 12.Locations
Sponsors and contacts
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George Mason University
Lead sponsor
Standard Process Inc.
Collaborator
Source ClinicalTrials.gov
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