Effects of Magnesium Breakthrough on Sleep Quality and Mood in Women With Poor Sleep: A Randomized, Double-Blind, Placebo-Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
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研究组 & 干预措施
Arm 2: Sequence BA (Placebo-Active)
干预措施: Placebo (Dietary Supplement)
Arm 2: Sequence BA (Placebo-Active)
干预措施: Magnesium Breakthrough (Dietary Supplement)
Arm 1: Sequence AB (Active-Placebo)
干预措施: Magnesium Breakthrough (Dietary Supplement)
Arm 1: Sequence AB (Active-Placebo)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Pittsburgh Sleep Quality Index (PSQI-2w) Global Score
时间窗: Baseline (start of each treatment period) to end of Period 1 (Week 2) and end of Period 2 (Week 5)
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
次要结局
- 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))
- Daily Visual Analogue Scale (VAS) Ratings for Sleep Quality, Energy, Fatigue, and Mood(Daily, throughout Period 1 (Weeks 1-2) and Period 2 (Weeks 4-5))
- 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))