Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels

NCT06979648 | Not Yet Recruiting

• 1 other identifier: QLS-011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnesium Deficiency

Keywords

Magnesium supplementation; magnesium

Outcome Measures

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.

  12 weeks

Secondary Outcomes (6)

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

  4, 8, and 12 weeks

• To assess perceived stress levels with the PSS-10

  4, 8, and 12 weeks

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

  4, 8, and 12 weeks

• Side effect profile as measured by a custom Safety and Tolerability survey

  4, 8, and 12 weeks

• To assess changes in serum magnesium levels

  4, 8, and 12 weeks

Study Arms (2)

Qualia Magnesium+®

ACTIVE COMPARATOR

Qualia Magnesium+® Supplement

Dietary Supplement: Qualia Magnesium+®

Placebo

PLACEBO COMPARATOR

Rice Flour

Dietary Supplement: Placebo

Interventions

Qualia Magnesium+® DIETARY_SUPPLEMENT

Qualia Magnesium+® manufactured by Qualia Life Sciences

Qualia Magnesium+®

Placebo DIETARY_SUPPLEMENT

Rice Flour

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qualia Life Sciences: lead

Study Sites (1)

Qualia Life Sciences

Carlsbad, California, 92011, United States

Location

MeSH Terms

Conditions

Magnesium Deficiency

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

William Scuba

CONTACT

855-281-2328; support@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: May 21, 2025
• Primary Completion: August 21, 2025
• Study Completion: September 21, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)