UCLA Magnesium Formulation Athlete Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Magnesium glycinate
  Blinded oral magnesium glycinate capsules taken nightly for 28 days.
• Пищевая добавка Magnesium L-threonate
  Blinded oral magnesium L-threonate capsules taken nightly for 28 days.
• Другое Placebo
  Matching placebo capsules taken nightly for 28 days.

Первичные конечные точки

• Change in WHOOP-derived sleep efficiency percentage from baseline week to final treatment week [Срок оценки: Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring]

Вторичные конечные точки (10)

• Change in BlazePod RIW Challenge reaction time in milliseconds from baseline to final visit [Срок оценки: Baseline to final visit, approximately 5 weeks]
• Change in BlazePod Speed Tap reaction time in milliseconds from baseline to final visit [Срок оценки: Baseline to final visit, approximately 5 weeks]
• Change in WHOOP-derived sleep consistency score from baseline week to final treatment week [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline to final visit, approximately 5 weeks]
• Change in VALD force plate countermovement jump height from baseline to final visit [Срок оценки: Baseline to final visit, approximately 5 weeks]
• Number of participants with adverse events and supplement tolerability concerns [Срок оценки: From first dose through final visit, approximately 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of California, Los Angeles — Los Angeles

Публикации

• Hausenblas HA, Lynch T, Hooper S, Shrestha A, Rosendale D, Gu J. Magnesium-L-threonate improves sleep quality and daytime functioning in adults with self-reported sleep problems: A randomized controlled trial. Sleep Med X. 2024 Aug 17;8:100121. doi: 10.1016/j.sleepx.2024.100121. eCollection 2024 Dec 15. PMID 39252819
• Schuster J, Cycelskij I, Lopresti A, Hahn A. Magnesium Bisglycinate Supplementation in Healthy Adults Reporting Poor Sleep: A Randomized, Placebo-Controlled Trial. Nat Sci Sleep. 2025 Aug 30;17:2027-2040. doi: 10.2147/NSS.S524348. eCollection 2025. PMID 40918053
• Mah J, Pitre T. Oral magnesium supplementation for insomnia in older adults: a Systematic Review & Meta-Analysis. BMC Complement Med Ther. 2021 Apr 17;21(1):125. doi: 10.1186/s12906-021-03297-z. PMID 33865376
• Walsh NP, Halson SL, Sargent C, Roach GD, Nedelec M, Gupta L, Leeder J, Fullagar HH, Coutts AJ, Edwards BJ, Pullinger SA, Robertson CM, Burniston JG, Lastella M, Le Meur Y, Hausswirth C, Bender AM, Grandner MA, Samuels CH. Sleep and the athlete: narrative review and 2021 expert consensus recommendations. Br J Sports Med. 2020 Nov 3:bjsports-2020-102025. doi: 10.1136/bjsports-2020-102025. Online ah PMID 33144349
• Miller DJ, Lastella M, Scanlan AT, Bellenger C, Halson SL, Roach GD, Sargent C. A validation study of the WHOOP strap against polysomnography to assess sleep. J Sports Sci. 2020 Nov;38(22):2631-2636. doi: 10.1080/02640414.2020.1797448. Epub 2020 Jul 26. PMID 32713257
• Gupta L, Morgan K, Gilchrist S. Does Elite Sport Degrade Sleep Quality? A Systematic Review. Sports Med. 2017 Jul;47(7):1317-1333. doi: 10.1007/s40279-016-0650-6. PMID 27900583

Идентификаторы

NCT: NCT07640685 · IRB-26-1185

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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