Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels

Qualia Life Sciences

Status: Not yet enrolling

Conditions: Magnesium Deficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Qualia Magnesium+®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06979648

QLS-011

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Qualia Magnesium+®

Active Comparator group

Description:

Qualia Magnesium+® Supplement

Treatment:

Dietary Supplement: Qualia Magnesium+®

Placebo

Placebo Comparator group

Description:

Rice Flour

Treatment:

Dietary Supplement: Placebo