UCLA Magnesium Formulation Athlete Study (Mg-Form)
Effects of Magnesium Glycinate and Magnesium L-Threonate on Sleep, Recovery, and Performance in Collegiate Athletes
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Jeremy Swisher, MD
- Puhelinnumero: 936-520-3595
- Sähköposti: jswisher@mednet.ucla.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Kimberly Burbank, MD
- Sähköposti: kburbank@mednet.ucla.edu
Opiskelupaikat
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California
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Los Angeles, California, Yhdysvallat, 90095
- University of California, Los Angeles
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Ottaa yhteyttä:
- Jeremy Swisher, MD
- Puhelinnumero: 936-520-3595
- Sähköposti: jswisher@mednet.ucla.edu
-
Ottaa yhteyttä:
- Kimberly Burbank, MD
- Sähköposti: kburbank@mednet.ucla.edu
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Kokeellinen: 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.
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Blinded oral magnesium glycinate capsules taken nightly for 28 days.
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Kokeellinen: 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.
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Blinded oral magnesium L-threonate capsules taken nightly for 28 days.
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Placebo Comparator: Placebo
Participants randomized to this arm will take matching placebo capsules nightly for 4 weeks on the same blinded schedule.
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Matching placebo capsules taken nightly for 28 days.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in WHOOP-derived sleep efficiency percentage from baseline week to final treatment week
Aikaikkuna: 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.
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Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in BlazePod RIW Challenge reaction time in milliseconds from baseline to final visit
Aikaikkuna: 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.
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Baseline to final visit, approximately 5 weeks
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Change in BlazePod Speed Tap reaction time in milliseconds from baseline to final visit
Aikaikkuna: 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.
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Baseline to final visit, approximately 5 weeks
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Change in WHOOP-derived sleep consistency score from baseline week to final treatment week
Aikaikkuna: Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
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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.
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Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
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Change in WHOOP-derived total sleep time in minutes from baseline week to final treatment week
Aikaikkuna: 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.
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Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
|
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Change in WHOOP-derived resting heart rate in beats per minute from baseline week to final treatment week
Aikaikkuna: 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.
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Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
|
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Change in WHOOP-derived heart rate variability in milliseconds from baseline week to final treatment week
Aikaikkuna: 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
|
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Change in WHOOP Recovery Score from baseline week to final treatment week
Aikaikkuna: 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.
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Baseline week to final treatment week, approximately 5 weeks total including baseline monitoring
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Change in VALD dynamometer bilateral average handgrip strength from baseline to final visit
Aikaikkuna: 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.
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Baseline to final visit, approximately 5 weeks
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Change in VALD force plate countermovement jump height from baseline to final visit
Aikaikkuna: Baseline to final visit, approximately 5 weeks
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Countermovement jump height will be measured with the prespecified VALD force plate protocol.
The outcome is final-visit jump height minus baseline jump height.
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Baseline to final visit, approximately 5 weeks
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Number of participants with adverse events and supplement tolerability concerns
Aikaikkuna: From first dose through final visit, approximately 4 weeks
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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.
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From first dose through final visit, approximately 4 weeks
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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Jeremy Swisher, MD, University of California, Los Angeles
- Opintojohtaja: Joshua Goldman, MD, University of California, Los Angeles
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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 ahead of print.
- 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.
- 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.
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- IRB-26-1185
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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