Magnesium Supplement for Sleep Quality in Women With Poor Sleep

NCT07708857 | Not Yet Recruiting

• 1 other identifier: WDL-MAG-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether a magnesium supplement (Magnesium Breakthrough) improves sleep quality and mood in women ages 35 to 60 who have poor sleep but no diagnosed sleep disorder. Participants will take the magnesium supplement for two weeks and a matched placebo for two weeks, in random order, separated by a one-week washout period. Neither participants nor study staff will know which product is being taken during each period. Throughout the study, participants will wear an Oura Ring to track sleep patterns and will complete short daily and biweekly questionnaires about their sleep, mood, stress, and energy levels. The main measure of interest is change in sleep quality, assessed using a validated sleep questionnaire (the Pittsburgh Sleep Quality Index). The study will also look at effects on mood, stress, and objective sleep measures from the Oura Ring. All study activities - screening, consent, and data collection - are conducted remotely, so participants can take part from anywhere in the United States.

Conditions

Sleep Quality

Keywords

magnesium; sleep quality; crossover trial; middle-aged women

Outcome Measures

Primary Outcomes (1)

• Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score

  The Pittsburgh Sleep Quality Index, modified 2-week recall version (PSQI-2w), is a validated self-report questionnaire assessing subjective sleep quality. Global scores range from 0 to 21, with scores greater than 5 indicating clinically meaningful poor sleep quality. The minimal clinically important difference (MCID) is 3 points. Change in global score will be calculated from period baseline to the end of each 2-week treatment period, comparing the magnesium supplementation condition to the placebo condition using a linear mixed-effects model accounting for treatment, sequence, and period effects. Higher scores indicate worse sleep quality. A higher score = greater poor sleep quality. A global score \>5 is the standard cutoff used to distinguish "poor" from "good" sleepers

  Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)

Secondary Outcomes (6)

• Change in Profile of Mood States (POMS) Score

  Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)

• Change in Perceived Stress Scale (PSS) Score

  Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)

• Change in Oura Ring Sleep Efficiency

  Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)

• Change in Oura Ring Total Sleep Time

  Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)

• Change in Oura Ring Sleep Onset Latency

  Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)

Study Arms (2)

Arm 1: Sequence AB (Active-Placebo)

EXPERIMENTAL

Dietary Supplement: Magnesium Breakthrough; Dietary Supplement: Placebo

Arm 2: Sequence BA (Placebo-Active)

EXPERIMENTAL

Dietary Supplement: Magnesium Breakthrough; Dietary Supplement: Placebo

Interventions

Magnesium Breakthrough DIETARY_SUPPLEMENT

Magnesium supplement blend (BIOptimizers), 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.

Arm 1: Sequence AB (Active-Placebo); Arm 2: Sequence BA (Placebo-Active)

Placebo DIETARY_SUPPLEMENT

Matched placebo capsules, identical in color, taste, smell, and packaging to Magnesium Breakthrough; 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.

Arm 1: Sequence AB (Active-Placebo); Arm 2: Sequence BA (Placebo-Active)

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 35-60 U.S.-based, fluent in English Insomnia Severity Index score ≥8 (poor/subclinical insomnia) and \<22 (excluding severe clinical insomnia) No formal sleep disorder diagnosis Consistent bedtime routine (+/-1 hr) Not currently using prescription sleep medications Owns a compatible smartphone (iOS or Android) capable of running the Oura Ring app and study digital platform Willing to wear the Oura Ring throughout the entire study period Nonsmoker Able to provide informed consent and complete all activities

You may not qualify if:

• Diagnosed sleep disorder Current diagnosis of depression or anxiety disorder Current use of bisphosphonates (e.g., alendronate, risedronate) Shift worker or highly irregular sleep schedule Pregnancy or breastfeeding Known sensitivity to product ingredients Current use of supplements containing more than 25 mg of elemental magnesium Coffee intake greater than 3 cups per day (or equivalent caffeine from other beverages) External or lifestyle factors that may affect sleep patterns (e.g., infant/child regularly wakening, excessive noise, snoring partner, pain condition, variable work/study schedule, or mid-to-late afternoon/evening caffeine intake) BMI ≥32 kg/m² Current diagnosis of chronic kidney disease or renal impairment, or current use of prescription diuretics Use of melatonin \>1 mg within 14 days of baseline Recent major life event or acute psychosocial stressor within 30 days of baseline (e.g., bereavement, job loss, separation) that may independently disrupt sleep Participation in other clinical trials in past 30 days
• Criteria:" as headers within a single text field)?

Sponsors & Collaborators

• Jacksonville University: lead

Study Sites (1)

Wellness Discovery Labs

Jacksonville, Florida, 32202, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Heather Hausenblas, PhD

  Wellness Discovery Labs, Jacksonville University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Hausenblas, PhD

CONTACT

904.891.9746; hhausenblas@wellnessdiscoverylabs.com

Stephanie Hooper, MPH

CONTACT

908.868.8740; shooper@wellnessdiscoverylabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, study staff, and data analysts will remain blinded to treatment assignment throughout the trial. The magnesium supplement and matched placebo will be identical in color, taste, smell, and packaging, and will be provided in coded bottles by the sponsor (BIOptimizers) until study completion, preventing identification of treatment assignment by participants or study personnel. The randomization sequence will be generated by the research team using a computer-generated program prior to enrollment; allocation will be concealed via the coded bottle system. Blinding integrity will be assessed at the end of each treatment period using a structured blinding assessment, in which participants will guess their treatment assignment and rate their confidence on a 5-point scale; the James Blinding Index will be calculated to quantify blinding effectiveness. Unblinding will occur only in the case of a reported adverse event or participant withdrawal.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified participant-level data will be made available upon reasonable written request to the Principal Investigator following publication of primary trial results. Requests will be reviewed by the Principal Investigator and BIOptimizers. Data will be shared in a secure format consistent with participant confidentiality protections and applicable data privacy regulations. The specific embargo period, duration of availability, and access terms will be defined in the sponsor agreement between BIOptimizers and Wellness Discovery Labs and specified prior to data sharing.
• Access Criteria: De-identified participant-level data and the study protocol will be available to qualified researchers upon written request to the Principal Investigator (Heather Hausenblas, PhD, Wellness Discovery Labs). Requests must include a description of the proposed use and analysis plan. Requests will be reviewed and approved by the Principal Investigator and BIOptimizers before data release. Approved requesters will receive de-identified, secure files consistent with participant confidentiality protections and applicable data privacy regulations (e.g., HIPAA). Data will be transferred via a secure, password-protected method. Access is limited to the approved data request and proposed use; re-use for purposes beyond the approved request requires a new request and review.

Locations

US (1)