An interventional study of Magnesium Breakthrough and Placebo in Sleep Quality, sponsored by Jacksonville University. Not yet recruiting at 1 site in United States. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Jacksonville University · Not applicable, Interventional, and Treatment
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.
Poor sleep quality affects a substantial proportion of adults, and women are disproportionately affected, particularly during the perimenopausal and postmenopausal transition. While Cognitive Behavioral Therapy for Insomnia (CBT-I) remains the gold-standard non-pharmacological treatment, access is limited. Pharmacological options such as benzodiazepines and common sleep aids carry risks of dependence, tolerance, and next-day cognitive impairment, while their objective sleep benefits are often modest. This has fueled interest in nutritional approaches to sleep support.
Magnesium is an essential mineral involved in numerous enzymatic processes relevant to neural and cardiovascular function. Suboptimal magnesium status is common and often undetected, and has been associated with shorter sleep duration and increased nocturnal awakenings. Emerging clinical trial evidence suggests magnesium supplementation may improve sleep efficiency, sleep onset latency, and subjective sleep quality, though the existing evidence base remains limited in scale and methodological rigor.
This study uses a randomized, double-blind, placebo-controlled crossover design, in which each participant serves as her own control, receiving both the active supplement and a matched placebo in a randomized sequence separated by a washout period. This design offers greater statistical power than a parallel-group design for a within-subject outcome such as self-reported sleep quality, while controlling for between-person variability.
The study uses fully decentralized methods: recruitment, screening, informed consent, and all data collection occur remotely via a secure digital platform, allowing participation from across the United States without requiring in-person site visits. Objective sleep data are collected continuously via a wearable device (Oura Ring), complementing validated self-report instruments to provide converging evidence across subjective and objective measures.
An a priori age-moderator analysis will explore whether treatment response varies across the 35-60 age range, given known differences in sleep physiology across the perimenopausal transition. Analyses account for standard crossover trial considerations, including treatment sequence, period effects, and carryover, with a washout period and behavioral standardization instructions designed to minimize carryover between treatment conditions.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 50 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Jacksonville University is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
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Dietary Supplement: Magnesium Breakthrough · Dietary Supplement: Placebo
Dietary Supplement: Magnesium Breakthrough · Dietary Supplement: Placebo
Magnesium supplement blend (BIOptimizers), 2 capsules taken orally nightly, 30 to 60 minutes before bedtime, for 2 weeks.
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.
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
Time frame: Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)
Change in Profile of Mood States (POMS) Score
The Profile of Mood States is a validated self-report questionnaire assessing mood disturbance across multiple subscales. The 40-item short form of the POMS-40, which measures six domains will be used: tension, anger, vigor, fatigue, depression, and confusion. A Total Mood score will be calculated. Change in total mood disturbance score will be calculated from baseline to the end of each treatment period, comparing the magnesium supplementation condition to placebo. On the five negative subscales (Tension, Depression, Anger, Fatigue, Confusion) higher scores = worse, more disturbance in that mood state. On Vigor higher scores = better (more energy/vigor). A Total Mood Disturbance score is calculated by summing the five negative subscales and subtracting Vigor-Activity. Each of the 40 items are rated on a 5-point Likert scale: where 0="not at all" and 4 ="extremely". Score range is 0 to 120.
Time frame: Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)
Change in Perceived Stress Scale (PSS) Score
The Perceived Stress Scale is a validated self-report measure of perceived stress over the preceding period. Change in score will be calculated from baseline to the end of each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model. Perceived Stress Scale (PSS): higher scores also mean greater perceived stress. The four item PSS will be used. The scores range of 0 to 16.
Time frame: Baseline, end of Period 1 (Week 2), and end of Period 2 (Week 5)
Change in Oura Ring Sleep Efficiency
Sleep efficiency (percentage of time in bed spent asleep) will be measured continuously via Oura Ring and averaged weekly for each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model.
Time frame: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Change in Oura Ring Total Sleep Time
Total sleep time will be measured continuously via Oura Ring and averaged weekly for each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model.
Time frame: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Change in Oura Ring Sleep Onset Latency
Sleep onset latency (time in minutes to fall asleep) will be measured continuously via Oura Ring and averaged weekly for each treatment period, comparing magnesium supplementation to placebo using a linear mixed-effects model.
Time frame: Weekly averages across Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Daily Visual Analogue Scale (VAS) Ratings for Sleep Quality, Energy, Fatigue, and Mood
Participants will complete daily visual analogue scale ratings (0-100) each morning during active treatment periods, assessing subjective sleep quality, energy, fatigue, and mood.
Time frame: Daily, throughout Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5)
Plan to share: Yes — De-identified participant-level data will be made available upon reasonable written request to the Principal Investigator following publication of the 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. Any embargo period and specific data sharing terms will be defined in the final executed sponsor agreement between BIOptimizers and Wellness Discovery Labs.
Supporting information: Study protocol
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Jacksonville University