UCLA Magnesium Formulation Athlete Study (Mg-Form)
Effects of Magnesium Glycinate and Magnesium L-Threonate on Sleep, Recovery, and Performance in Collegiate Athletes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Jeremy Swisher, MD
- Phone Number: 936-520-3595
- Email: jswisher@mednet.ucla.edu
Study Contact Backup
- Name: Kimberly Burbank, MD
- Email: kburbank@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
Contact:
- Jeremy Swisher, MD
- Phone Number: 936-520-3595
- Email: jswisher@mednet.ucla.edu
-
Contact:
- Kimberly Burbank, MD
- Email: kburbank@mednet.ucla.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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.
|
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.
|
Blinded oral magnesium L-threonate capsules taken nightly for 28 days.
|
|
Placebo Comparator: Placebo
Participants randomized to this arm will take matching placebo capsules nightly for 4 weeks on the same blinded schedule.
|
Matching placebo capsules taken nightly for 28 days.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in WHOOP-derived sleep efficiency percentage from baseline week to final treatment week
Time Frame: 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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in BlazePod RIW Challenge reaction time in milliseconds from baseline to final visit
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jeremy Swisher, MD, University of California, Los Angeles
- Study Director: Joshua Goldman, MD, University of California, Los Angeles
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IRB-26-1185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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