Elevated Blood GlucoseNCT07865351
Whole-Food Magnesium for Mental and Cardiometabolic Health
A study testing Low-Dose Whole-Food-Based Magnesium Supplement and Moderate-Dose Whole-Food-Based Magnesium Supplement in people with Elevated Blood Glucose, run by George Mason University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Elevated Blood Glucose
- What is being tested?
- Low-Dose Whole-Food-Based Magnesium Supplement and Moderate-Dose Whole-Food-Based Magnesium Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- BMI 18.5-29.9 kg/m²
- HbA1c 5.7%-6.4%
- Stable medication regimen for at least 3 months
- Individuals taking a stable dose of metformin may be included
Who cannot join
- Severe psychiatric or sleep disorders
- Diagnosed diabetes
- Pregnancy or breastfeeding
- Clinically significant thyroid, kidney, liver, or pancreatic disease
- Active cancer
- Known iron overload
Show all 13Show fewer
- History of bariatric surgery
- Heavy smoking
- Heavy alcohol use
- Uncontrolled hypertension
- Current supplement use that may interact with study outcomes
- Current participation in an active weight-loss program or use of weight-loss medications
- Current participation in another clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Organic Whole-Food Magnesium (E-Z MgTM) on Mood, Fatigue, Sleep, and Cardiometabolic Outcomes in Adults With Elevated Blood Glucose
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.
Read more
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.
- Conditions
- Elevated Blood Glucose
- Being tested
- Low-Dose Whole-Food-Based Magnesium Supplement, Moderate-Dose Whole-Food-Based Magnesium Supplement, Placebo
- Keywords
- Magnesium, E-Z Mg, Sleep, Mood, Fatigue, Glycemic Control, Insulin Sensitivity, CGM, Cardiometabolic Health
- Medical subject headings
- Hyperglycemia, Fatigue, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Whole-Food-Based Magnesium SupplementDietary 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 SupplementDietary 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Whole-Food-Based Magnesium Supplement | Experimental | Participants will receive E-Z Mg™, providing 70 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education. Receives: Dietary Supplement: Low-Dose Whole-Food-Based Magnesium Supplement |
| Moderate-Dose Whole-Food-Based Magnesium Supplement Placebo | Experimental | Participants will receive E-Z Mg™, providing 140 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education. Receives: Dietary Supplement: Moderate-Dose Whole-Food-Based Magnesium Supplement |
| Placebo | Placebo comparator | Participants will receive a placebo containing no magnesium for 12 weeks. Participants will also receive standardized nutrition education. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective Sleep Disturbance
Change in subjective sleep outcomes assessed using the PROMIS Sleep Disturbance and PROMIS Sleep-Related Impairment questionnaires.
Measured: Baseline, Week 6, and Week 12
Change in Objective Sleep Measures
Change in objective sleep measures assessed using wrist-worn actigraphy.
Measured: Baseline, Week 6, and Week 12
Change in Anxiety Symptoms
Change in anxiety symptoms assessed using the PROMIS Emotional Distress-Anxiety questionnaire.
Measured: Baseline, Week 6, and Week 12
Change in Depressive Symptoms
Change in depressive symptoms assessed using the PROMIS Emotional Distress-Depression questionnaire.
Measured: Baseline, Week 6, and Week 12
Change in Fatigue
Change in fatigue assessed using the PROMIS Fatigue questionnaire.
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (10)
Change in Glycemic Control
Glycemic control will be assessed using fasting glucose concentration (mg/dL) measured from fasting blood samples
Measured: 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.
Measured: Baseline, Week 6, and Week 12.
Change in Continuous Glucose Monitoring Measures
Assessed using CGM-derived glucose metrics.
Measured: Baseline, Week 6, and Week 12.
Change in Lipid Profile
Assessed using fasting lipid measurements.
Measured: Baseline, Week 6, and Week 12.
Change in Inflammation
Assessed using high-sensitivity C-reactive protein (hs-CRP).
Measured: Baseline, Week 6, and Week 12.
Change in Liver Enzymes
Assessed using ALT and AST.
Measured: Baseline, Week 6, and Week 12.
Change in Blood Pressure
Assessed using resting systolic and diastolic blood pressure.
Measured: Baseline, Week 6, and Week 12.
Change in Anthropometric Measures and Body Composition
Assessed using body weight, BMI, and body composition measurements.
Measured: Baseline, Week 6, and Week 12.
Change in Dietary Intake
Assessed using dietary intake records.
Measured: 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.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- Standard Process Inc.
- Responsible party
- Principal investigator, Raedeh Basiri, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865351
- Sponsor's protocol ID
- STUDY00001432
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Organic Whole-Food Magnesium (E-Z MgTM) on Mood, Fatigue, Sleep, and Cardiometabolic Outcomes in Adults With Elevated Blood Glucose
- ClinicalTrials.gov ID
- NCT07865351
- Acronym / sponsor ID
- STUDY00001432
- Conditions
- Elevated Blood Glucose
- Keywords
- Magnesium, E-Z Mg, Sleep, Mood, Fatigue, Glycemic Control, Insulin Sensitivity, CGM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- Standard Process Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Whole-Food-Based Magnesium Supplement | Experimental | Dietary Supplement: Low-Dose Whole-Food-Based Magnesium SupplementParticipants will receive E-Z Mg™, providing 70 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education. |
| Moderate-Dose Whole-Food-Based Magnesium Supplement Placebo | Experimental | Dietary Supplement: Moderate-Dose Whole-Food-Based Magnesium SupplementParticipants will receive E-Z Mg™, providing 140 mg elemental magnesium per day, for 12 weeks. Participants will also receive standardized nutrition education. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a placebo containing no magnesium for 12 weeks. Participants will also receive standardized nutrition education. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40-70 years
- BMI 18.5-29.9 kg/m²
- HbA1c 5.7%-6.4%
- Stable medication regimen for at least 3 months
- Individuals taking a stable dose of metformin may be included
Key exclusion criteria (13 listed)
- Severe psychiatric or sleep disorders
- Diagnosed diabetes
- Pregnancy or breastfeeding
- Clinically significant thyroid, kidney, liver, or pancreatic disease
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose Whole-Food-Based Magnesium SupplementParticipants assigned to an active intervention arm will receive either 70 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment. | Dietary supplement | Low-Dose Whole-Food-Based Magnesium Supplement |
| Moderate-Dose Whole-Food-Based Magnesium SupplementParticipants assigned to an active intervention arm will receive either 140 mg of elemental magnesium daily for 12 weeks, according to randomized group assignment. | Dietary supplement | Moderate-Dose Whole-Food-Based Magnesium Supplement Placebo |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
Change in Subjective Sleep Disturbance
Time frame: Baseline, Week 6, and Week 12
Change in subjective sleep outcomes assessed using the PROMIS Sleep Disturbance and PROMIS Sleep-Related Impairment questionnaires.
Change in Objective Sleep Measures
Time frame: Baseline, Week 6, and Week 12
Change in objective sleep measures assessed using wrist-worn actigraphy.
Change in Anxiety Symptoms
Time frame: Baseline, Week 6, and Week 12
Change in anxiety symptoms assessed using the PROMIS Emotional Distress-Anxiety questionnaire.
Change in Depressive Symptoms
Time frame: Baseline, Week 6, and Week 12
Change in depressive symptoms assessed using the PROMIS Emotional Distress-Depression questionnaire.
Change in Fatigue
Time frame: Baseline, Week 6, and Week 12
Change in fatigue assessed using the PROMIS Fatigue questionnaire.
10 secondary outcomes
Change in Glycemic Control
Time frame: Baseline, Week 6, and Week 12.
Change in Insulin Sensitivity/Resistance
Time frame: Baseline, Week 6, and Week 12.
Change in Continuous Glucose Monitoring Measures
Time frame: Baseline, Week 6, and Week 12.
Change in Lipid Profile
Time frame: Baseline, Week 6, and Week 12.
Change in Inflammation
Time frame: Baseline, Week 6, and Week 12.
Change in Liver Enzymes
Time frame: Baseline, Week 6, and Week 12.
Change in Blood Pressure
Time frame: Baseline, Week 6, and Week 12.
Change in Anthropometric Measures and Body Composition
Time frame: Baseline, Week 6, and Week 12.
Change in Dietary Intake
Time frame: Baseline, Week 6, and Week 12.
Change in Long-Term Glycemic Control
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Elevated Blood Glucose
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Whole-Food-Based Magnesium Supplement and Moderate-Dose Whole-Food-Based Magnesium Supplement in people with Elevated Blood Glucose, run by George Mason University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raedeh Basiri, PhD,RDN (7039936575, rbasiri@gmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Sleep Disturbance (time frame: Baseline, Week 6, and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.