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| Name | Class |
|---|---|
| Pure Encapsulations | INDUSTRY |
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The purpose of this study is to assess whether 480 mg/day magnesium glycinate supplementation for 12 weeks lowers blood pressure.
This clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure in 120 adults aged 30-74 who have a systolic blood pressure of 130-154 mmHg.
Eligibility to participate in the trial will be determined by a 2-stage screening process. Interested participants will complete a pre-screening form online. If eligibility criteria are met, the potential participants will be scheduled for an in-person screening clinic visit. At the visit, eligible participants will be reminded about the study details and potential risks and will be given the opportunity to sign the Informed Consent. Consented participants will be assigned by chance (like a coin toss) to daily magnesium or to placebo. Participants will take 4 study capsules per day (2 capsules in the morning and 2 capsules in the evening) for 12 weeks.
Assessments at the screening visit include seated blood pressure; pulse; weight, height, waist and hip circumference measurements; fasting blood and urine collection; and health and diet questionnaires. Participants will return for a clinic visit at 12 weeks to assess these measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnesium | Active Comparator | magnesium glycinate supplement, 480 mg/day |
|
| placebo | Placebo Comparator | placebo supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium glycinate supplement | Dietary Supplement | magnesium glycinate (480 mg/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in seated systolic blood pressure from baseline to 12 weeks | Baseline and 12 week | |
| Change in seated diastolic blood pressure from baseline to 12 weeks | Baseline and 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum magnesium levels from baseline to 12 weeks | Baseline and 12 week | |
| Change in RBC magnesium levels from baseline to 12 weeks | Baseline and 12 week | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
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| placebo |
| Dietary Supplement |
placebo |
|
| Whether the effect of magnesium on seated blood pressure is modified by baseline serum and/or RBC magnesium |
| Baseline and 12 week |