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Not yet recruiting NCT06979648

Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels

No phase Interventional Magnesium Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Qualia Magnesium+®, Placebo.
Who it may be relevant to
Registry conditions: Magnesium Deficiency. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels: A Randomized Double-Blind Parallel Trial

Overview

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 supplement Qualia Magnesium+®
    Qualia Magnesium+® manufactured by Qualia Life Sciences
  • Dietary supplement Placebo
    Rice Flour

Primary outcome measures

  • Between-group change in RBC magnesium levels [Time frame: 12 weeks]
Secondary outcome measures (6)
  • 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 [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Qualia Life Sciences — Carlsbad

Identifiers

NCT: NCT06979648 · QLS-011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗