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NCT Number: NCT06979648

Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels

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.

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Key information

Conditions

Magnesium Deficiency Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualia Magnesium+®

Dietary Supplement

Qualia Magnesium+® manufactured by Qualia Life Sciences

Placebo

Dietary Supplement

Rice Flour

Primary outcomes

  1. Between-group change in RBC magnesium levels

    Time frame: 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 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

    Time frame: 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

  5. To assess changes in serum magnesium levels

    Time frame: 4, 8, and 12 weeks

  6. Between-group change in RBC magnesium levels

    Time frame: 4 and 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

William Scuba

CONTACT

[email protected]

855-281-2328

Sponsors and collaborators

Lead sponsor

Qualia Life Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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