About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Magnesium Breakthrough
- Placebo