此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

UCLA Magnesium Formulation Athlete Study (Mg-Form)

2026年6月5日 更新者：Jeremy Swisher, MD、University of California, Los Angeles

Effects of Magnesium Glycinate and Magnesium L-Threonate on Sleep, Recovery, and Performance in Collegiate Athletes

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Magnesium Glycinate
Participants randomized to this arm will take blinded magnesium glycinate capsules nightly for 4 weeks. The current planning dose is approximately 240 mg elemental magnesium nightly, with final capsule count and label language based on the selected blinded formulation.
膳食补充剂：Magnesium glycinate
Blinded oral magnesium glycinate capsules taken nightly for 28 days.
实验性的：Magnesium L-Threonate
Participants randomized to this arm will take blinded magnesium L-threonate capsules nightly for 4 weeks. The current planning target is approximately 2 g/day total magnesium L-threonate, with elemental magnesium content, capsule count, and label language confirmed before activation.
膳食补充剂：Magnesium L-threonate
Blinded oral magnesium L-threonate capsules taken nightly for 28 days.
安慰剂比较：Placebo
Participants randomized to this arm will take matching placebo capsules nightly for 4 weeks on the same blinded schedule.
其他：Placebo
Matching placebo capsules taken nightly for 28 days.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in WHOOP-derived sleep efficiency percentage from baseline week to final treatment week
大体时间：Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Average nightly WHOOP-derived sleep efficiency, expressed as a percentage, will be calculated for the baseline week and final treatment week. A valid week requires at least 5 usable nights in the 7-day window. The outcome is final-treatment-week average minus baseline-week average; higher values indicate improved sleep efficiency.
Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring

次要结果测量

结果测量
措施说明
大体时间
Change in BlazePod RIW Challenge reaction time in milliseconds from baseline to final visit
大体时间：Baseline to final visit, approximately 5 weeks
Reaction performance will be measured using the prespecified BlazePod RIW Challenge protocol. The outcome is change in reaction time in milliseconds from baseline to final visit. Lower reaction time indicates better performance.
Baseline to final visit, approximately 5 weeks
Change in BlazePod Speed Tap reaction time in milliseconds from baseline to final visit
大体时间：Baseline to final visit, approximately 5 weeks
Reaction performance will be measured using the prespecified BlazePod Speed Tap protocol. The outcome is change in reaction time in milliseconds from baseline to final visit. Lower reaction time indicates better performance.
Baseline to final visit, approximately 5 weeks
Change in WHOOP-derived sleep consistency score from baseline week to final treatment week
大体时间：Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
WHOOP-derived sleep consistency score, or an equivalent prespecified wearable-derived sleep timing regularity metric, will be summarized for the baseline week and final treatment week. The outcome is final-treatment-week average minus baseline-week average.
Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Change in WHOOP-derived total sleep time in minutes from baseline week to final treatment week
大体时间：Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Average nightly total sleep time captured by WHOOP, expressed in minutes, will be calculated for the baseline week and final treatment week. The outcome is final-treatment-week average minus baseline-week average.
Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Change in WHOOP-derived resting heart rate in beats per minute from baseline week to final treatment week
大体时间：Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Nightly resting heart rate captured by WHOOP, expressed in beats per minute, will be summarized as weekly averages for the baseline week and final treatment week. The outcome is final-treatment-week average minus baseline-week average.
Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Change in WHOOP-derived heart rate variability in milliseconds from baseline week to final treatment week
大体时间：Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Nightly heart rate variability captured by WHOOP, expressed in milliseconds, will be summarized as weekly averages for the baseline week and final treatment week. The outcome is final-treatment-week average minus baseline-week average.
Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Change in WHOOP Recovery Score from baseline week to final treatment week
大体时间：Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
WHOOP Recovery Score, reported on a 0 to 100 scale where higher scores indicate better recovery, will be summarized as weekly averages for the baseline week and final treatment week. The outcome is final-treatment-week average minus baseline-week average.
Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
Change in VALD dynamometer bilateral average handgrip strength from baseline to final visit
大体时间：Baseline to final visit, approximately 5 weeks
Bilateral average handgrip strength will be measured with the prespecified VALD handgrip dynamometer protocol. The outcome is final-visit bilateral average handgrip strength minus baseline bilateral average handgrip strength.
Baseline to final visit, approximately 5 weeks
Change in VALD force plate countermovement jump height from baseline to final visit
大体时间：Baseline to final visit, approximately 5 weeks
Countermovement jump height will be measured with the prespecified VALD force plate protocol. The outcome is final-visit jump height minus baseline jump height.
Baseline to final visit, approximately 5 weeks
Number of participants with adverse events and supplement tolerability concerns
大体时间：From first dose through final visit, approximately 4 weeks
The number of participants with adverse events, tolerability concerns, dose interruptions, and study-product discontinuations will be summarized by study arm. Events of interest include gastrointestinal symptoms, sedation, dizziness, headache, allergic reaction, skin irritation from wearable use, and study-product discontinuation.
From first dose through final visit, approximately 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of California, Los Angeles

调查人员

  • 首席研究员：Jeremy Swisher, MD、University of California, Los Angeles
  • 研究主任：Joshua Goldman, MD、University of California, Los Angeles

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年6月5日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB-26-1185

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

No individual participant data sharing is planned because the study involves a relatively small cohort of collegiate athletes and individual-level sleep, recovery, performance, and sport-related data may create re-identification risk. Aggregate results may be disseminated through presentations, manuscripts, and ClinicalTrials.gov summaries as applicable.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅