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This is a randomized, double-blind, placebo-controlled parallel trial designed to evaluate the effectiveness of Qualia Magnesium+® supplementation on red blood cell (RBC) magnesium levels in adults aged 21 and older. Approximately 100 participants with baseline RBC magnesium levels below 6.0 mg/dL will be randomly assigned to receive either Qualia Magnesium+ or a placebo. Participants will take 2 capsules daily in the evening, with or without food, for a duration of 12 weeks. The primary outcome is the between-group change in RBC magnesium levels from baseline to Week 12. Secondary outcomes include assessments of sleep quality, perceived stress, magnesium status, and safety and tolerability. Data collection will occur through lab bloodwork and electronic questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualia Magnesium+® | Active Comparator | Qualia Magnesium+® Supplement |
|
| Placebo | Placebo Comparator | Rice Flour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualia Magnesium+® | Dietary Supplement | Qualia Magnesium+® manufactured by Qualia Life Sciences |
|
| Measure | Description | Time Frame |
|---|---|---|
| Between-group change in RBC magnesium levels | To assess the between-group change in RBC magnesium levels from baseline to Week 12 following supplementation with Qualia Magnesium+ or placebo. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate changes in sleep quality using the PROMIS Sleep Disturbance Short Form | 4, 8, and 12 weeks | |
| To assess perceived stress levels with the PSS-10 | 4, 8, and 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Scuba | Contact | 855-281-2328 | support@qualialife.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qualia Life Sciences | Carlsbad | California | 92011 | United States |
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| ID | Term |
|---|---|
| D008275 | Magnesium Deficiency |
| ID | Term |
|---|---|
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Rice Flour |
|
| To evaluate changes in the magnesium status using the Magnesium Status Questionnaire |
| 4, 8, and 12 weeks |
| Side effect profile as measured by a custom Safety and Tolerability survey | Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey | 4, 8, and 12 weeks |
| To assess changes in serum magnesium levels | 4, 8, and 12 weeks |
| Between-group change in RBC magnesium levels | 4 and 8 weeks |