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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
100
Qualia Magnesium+® manufactured by Qualia Life Sciences
Rice Flour
Qualia Life Sciences
Carlsbad, California, United States
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.
Time frame: 12 weeks
To evaluate changes in sleep quality using the PROMIS Sleep Disturbance Short Form
Time frame: 4, 8, and 12 weeks
To assess perceived stress levels with the PSS-10
Time frame: 4, 8, and 12 weeks
To evaluate changes in the magnesium status using the Magnesium Status Questionnaire
Time frame: 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
Time frame: 4, 8, and 12 weeks
To assess changes in serum magnesium levels
Time frame: 4, 8, and 12 weeks
Between-group change in RBC magnesium levels
Time frame: 4 and 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.