Health TrialsbyHealthPanel

Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels

ConditionMagnesium Deficiency
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorQualia Life Sciences

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Qualia Magnesium+®

    Dietary supplement

    Qualia Magnesium+® manufactured by Qualia Life Sciences

  • Placebo

    Dietary supplement

    Rice Flour

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Qualia Magnesium+®Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

To evaluate changes in sleep quality using the PROMIS Sleep Disturbance Short Form

Time frame
4, 8, and 12 weeks
2

To assess perceived stress levels with the PSS-10

Time frame
4, 8, and 12 weeks
3

To evaluate changes in the magnesium status using the Magnesium Status Questionnaire

Time frame
4, 8, and 12 weeks
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qualia Life Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: