Effects of Magnesium Glycinate and Magnesium L-Threonate on Sleep, Recovery, and Performance in Collegiate Athletes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial will compare magnesium glycinate, magnesium L-threonate, and placebo in UCLA varsity athletes. Participants will complete a baseline monitoring period followed by 4 weeks of blinded nightly supplementation. WHOOP or study-approved wearable data will be used to evaluate sleep efficiency, total sleep time, sleep consistency, heart rate variability, resting heart rate, and recovery metrics. Baseline and final testing will assess selected reaction and physical performance outcomes. The primary outcome is change in WHOOP-derived sleep efficiency from baseline week to final treatment week.
详细描述
Magnesium is involved in neuromuscular signaling, cellular energy metabolism, autonomic regulation, and sleep-related physiology. Competitive athletes often experience sleep restriction, training stress, travel, soreness, and recovery demands. Magnesium glycinate and magnesium L-threonate are commonly used athlete-facing magnesium formulations, but they are not interchangeable. Glycinate is commonly positioned as a well-tolerated sleep-oriented formulation, whereas L-threonate is of interest because of prior signals related to sleep, cognition, reaction performance, and central nervous system magnesium biology. This single-site UCLA study will enroll adult varsity athletes aged 18 to 35 years. Participants will complete screening, informed consent, baseline assessments, wearable monitoring, a baseline monitoring period, randomization in a 1:1:1 ratio, 4 weeks of blinded nightly capsules, brief daily REDCap morning surveys, weekly adherence and safety check-ins, and final performance-adjacent testing. The primary outcome is change in average WHOOP-derived sleep efficiency from baseline week to final treatment week. Prespecified primary contrasts will compare magnesium glycinate versus placebo and magnesium L-threonate versus placebo. Total sleep time, sleep consistency, resting heart rate, heart rate variability, WHOOP Recovery Score, reaction-time performance, grip strength, countermovement jump height, adherence, tolerability, and adverse events will be analyzed as secondary or exploratory outcomes according to the final statistical analysis plan. The magnesium glycinate versus magnesium L-threonate contrast will be treated as exploratory unless the final statistical analysis plan preserves alpha for that comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, study personnel involved in assessment, investigators, and outcome assessors will remain blinded to treatment assignment. The primary analysis will also be performed with treatment assignment masked when feasible. Emergency unblinding may occur only when needed for participant safety or regulatory requirements.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 35 years.
- •Current UCLA varsity athlete.
- •Actively training or competing during the study period.
- •Willing to wear WHOOP or a study-approved wearable device continuously during baseline and treatment periods if wearable data are used.
- •Willing to take assigned study capsules nightly for 28 days.
- •Willing to complete brief daily REDCap surveys and weekly adherence/safety check-ins.
- •Able to provide informed consent and comply with study procedures.
排除标准
- •Current magnesium supplementation without completion of an appropriate washout before baseline.
- •Current investigational drug or investigational supplement use.
- •Current use of prescription or over-the-counter sleep medications unless reviewed and permitted by the study clinician.
- •Diagnosed sleep disorder that, in the investigator's judgment, would confound outcomes or increase risk.
- •Significant kidney disease or another medical condition that may increase risk with magnesium supplementation.
- •Known intolerance or allergy to magnesium glycinate, magnesium L-threonate, placebo, or inactive study ingredients.
- •Use of medications with clinically relevant magnesium interactions unless reviewed and permitted by the study clinician.
- •Any other condition that, in the investigator's judgment, would make participation unsafe, compromise voluntary consent, or prevent valid outcome assessment.
研究者
Jeremy Swisher, MD
Principal Investigator
University of California, Los Angeles