Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

UCLA Magnesium Formulation Athlete Study (Mg-Form)

5. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Magnesium glycinate
Blinded oral magnesium glycinate capsules taken nightly for 28 days.
Eksperimentell: 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.
Kosttilskudd: Magnesium L-threonate
Blinded oral magnesium L-threonate capsules taken nightly for 28 days.
Placebo komparator: Placebo
Participants randomized to this arm will take matching placebo capsules nightly for 4 weeks on the same blinded schedule.
Annen: Placebo
Matching placebo capsules taken nightly for 28 days.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in WHOOP-derived sleep efficiency percentage from baseline week to final treatment week
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in BlazePod RIW Challenge reaction time in milliseconds from baseline to final visit
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Los Angeles

Etterforskere

  • Hovedetterforsker: Jeremy Swisher, MD, University of California, Los Angeles
  • Studieleder: Joshua Goldman, MD, University of California, Los Angeles

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

26. mai 2026

Først innsendt som oppfylte QC-kriteriene

5. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-26-1185

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Sove

Kliniske studier på Magnesium glycinate

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Uganda

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere