Clinical trial NCT06979648: Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels
Official title: Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels: A Randomized Double-Blind Parallel Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Magnesium Deficiency
Keywords: Magnesium supplementation
magnesium
Lead sponsor: Qualia Life Sciences
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Between-group change in RBC magnesium levels
timeFrame: 12 weeks
Secondary outcomes:
measure: To evaluate changes in sleep quality using the PROMIS Sleep Disturbance Short Form
timeFrame: 4, 8, and 12 weeks
measure: To assess perceived stress levels with the PSS-10
timeFrame: 4, 8, and 12 weeks
measure: To evaluate changes in the magnesium status using the Magnesium Status Questionnaire
timeFrame: 4, 8, and 12 weeks
measure: Side effect profile as measured by a custom Safety and Tolerability survey
timeFrame: 4, 8, and 12 weeks
measure: To assess changes in serum magnesium levels
timeFrame: 4, 8, and 12 weeks
measure: Between-group change in RBC magnesium levels
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Qualia Life Sciences
state: California
Study officials:
References: