Magnesium Deficiency
Conditions
Keywords
Magnesium supplementation, magnesium
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTQualia Magnesium+®
Qualia Magnesium+® manufactured by Qualia Life Sciences
DIETARY_SUPPLEMENTPlacebo
Rice Flour
Sponsors
Qualia Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide voluntary, written, informed consent to participate in the study * Agree to provide a valid cell phone number and are willing to receive communications through text * Can read and write English * Willing to complete questionnaires, records, and diaries associated with the study. * Male and female participants aged 21 years and older * Willing and able to visit a local blood draw facility for required blood sample collections * Live within 20 miles of a suitable blood draw facility (such as Quest) * RBC Magnesium levels below 6.0 mg/dL * Willing to not consume any supplements containing magnesium starting about 2 weeks prior to the baseline magnesium blood test and continuing through the intervention period. * Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly with the exception of those containing magnesium
Exclusion criteria
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial * Known food intolerances/allergy to any ingredients in the product * Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer * Having had a significant cardiovascular event in the past 6 months * Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines * On immunosuppressive therapy * Individuals who were deemed incompatible with the test protocol * Adults lacking capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-group change in RBC magnesium levels | 12 weeks | To assess the between-group change in RBC magnesium levels from baseline to Week 12 following supplementation with Qualia Magnesium+ or placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess perceived stress levels with the PSS-10 | 4, 8, and 12 weeks | — |
| To evaluate changes in the magnesium status using the Magnesium Status Questionnaire | 4, 8, and 12 weeks | — |
| To evaluate changes in sleep quality using the PROMIS Sleep Disturbance Short Form | 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 | — |
| Side effect profile as measured by a custom Safety and Tolerability survey | 4, 8, and 12 weeks | Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey |
Countries
United States
Contacts
Primary ContactWilliam Scuba
Outcome results
None listed