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UCLA Magnesium Formulation Athlete Study (Mg-Form)

5 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Suplemento dietético: Magnesium glycinate
Blinded oral magnesium glycinate capsules taken nightly for 28 days.
Experimental: 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.
Suplemento dietético: Magnesium L-threonate
Blinded oral magnesium L-threonate capsules taken nightly for 28 days.
Comparador de Placebo: Placebo
Participants randomized to this arm will take matching placebo capsules nightly for 4 weeks on the same blinded schedule.
Outro: Placebo
Matching placebo capsules taken nightly for 28 days.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in WHOOP-derived sleep efficiency percentage from baseline week to final treatment week
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in BlazePod RIW Challenge reaction time in milliseconds from baseline to final visit
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of California, Los Angeles

Investigadores

  • Investigador principal: Jeremy Swisher, MD, University of California, Los Angeles
  • Diretor de estudo: Joshua Goldman, MD, University of California, Los Angeles

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

26 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB-26-1185

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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