Creatine for Recovery and Thinking in Mothers (CREATE-MOM)
26 augustus 2026 bijgewerkt door: University of North Carolina, Chapel Hill
Creatine for Recovery, Executive Function, Activity, Thinking & Energy in Mothers (CREATE-MOM)
The purpose of this randomized, double-blind, parallel-group trial is to compare the effects of two doses of creatine monohydrate (5 g/day versus 10 g/day) administered for four weeks in postpartum women.
The study will evaluate exercise performance, post-exercise recovery, cognitive function, and brain creatine concentrations in a sub-sample.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Postpartum women frequently experience changes in physical performance, recovery, cognition, sleep quality, and mood.
Creatine supplementation may enhance energy availability in skeletal muscle and brain tissue, potentially improving exercise performance, recovery, and cognitive function.
This study will enroll 40 postpartum women and randomly assign participants in a 1:1 ratio to receive either 5 g/day or 10 g/day of creatine monohydrate for four weeks in a double-blind fashion.
Assessments will be conducted before and after supplementation and will include repeated sprint ability testing, skeletal muscle oxygen recovery, and cognitive testing.
A subsample of 20 participants will undergo magnetic resonance spectroscopy to assess brain creatine stores.
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Abbie Smith-Ryan, PhD
- Telefoonnummer: 919-962-2574
- E-mail: abbiesmith@unc.edu
Studie Contact Back-up
- Naam: Research Coordinator
- Telefoonnummer: 919-962-1663
- E-mail: aplresearch@unc.edu
Studie Locaties
-
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599
- Applied Physiology Laboratory
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Contact:
- Study Coordinator
- Telefoonnummer: 919-962-1663
- E-mail: aplresearch@unc.edu
-
Hoofdonderzoeker:
- Abbie Smith-Ryan, PhD
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- 6 weeks -12 months postpartum
- Body mass index of 18.5-34.9 kg/m2
- Cleared to resume physical activity
Exclusion Criteria:
- Experienced a musculoskeletal injury, excluding a Cesarean delivery,within the past three months that inhibits participation in the study.
- Has chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer
- Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).
- Has uncontrolled hypertension or diabetes, or has recently started medication, without a stable dose for 3 consecutive months.
- Currently using creatine monohydrate or other performance-enhancing supplements
- Has a self-identified or clinically diagnosed eating disorder
- Taking or having supplemented with creatine monohydrate in the last 28-days
- Medical contradictions for physical exercise
- Has participated in another clinical trial within 4-weeks prior to enrollment that in the opinion of the PI would influence the results.
- Has severely impaired hearing or speech or inability to speak English.
- Unwilling or unable to comply with the study protocol, including abstaining from caffeine, tobacco, alcohol, and physical activity before testing days.
- Is currently pregnant.
- Has a known allergy to the transducer gel used for the ultrasound
- Has a known allergy to creatine monohydrate
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Low-Dose Creatine Monohydrate
Participants consume 5 grams per day of creatine monohydrate for 28 consecutive days.
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Creatine monohydrate taken daily mixed with 6-8 oz of water.
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Experimenteel: High-dose Creatine Monohydrate
Participants consume 10 grams per day of creatine monohydrate for 28 consecutive days.
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Creatine monohydrate taken daily mixed with 6-8 oz of water.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Repeated Sprint Ability Peak Power
Tijdsspanne: Change from baseline to 4 weeks post-supplementation.
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Peak power (Watts) measured during a repeated sprint ability cycling test.
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Change from baseline to 4 weeks post-supplementation.
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Fatigue Index
Tijdsspanne: Change from baseline to 4 weeks post-supplementation.
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Fatigue index (%) calculated from repeated sprint ability testing.
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Change from baseline to 4 weeks post-supplementation.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Skeletal Muscle Oxygen Recovery
Tijdsspanne: Change from baseline to 4 weeks post-supplementation
|
Recovery rate constant of skeletal muscle oxygen consumption following exercise measured by near-infrared spectroscopy and arterial occlusion procedures.
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Change from baseline to 4 weeks post-supplementation
|
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Executive Function
Tijdsspanne: Change from baseline to 4 weeks post-supplementation
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Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.
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Change from baseline to 4 weeks post-supplementation
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Working Memory
Tijdsspanne: Change in baseline to 4 weeks post-supplementation.
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Working memory measured using the NIH Toolbox List Sorting Working Memory Test.
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Change in baseline to 4 weeks post-supplementation.
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Brain Creatine Concentration
Tijdsspanne: Change from baseline to 4 weeks post-supplementation
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Brain phosphocreatine and related bioenergetic metabolites assessed using phosphorus magnetic resonance spectroscopy (³¹P-MRS) in the imaging subsample
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Change from baseline to 4 weeks post-supplementation
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
8 september 2026
Primaire voltooiing (Geschat)
10 mei 2027
Studie voltooiing (Geschat)
10 mei 2027
Studieregistratiedata
Eerst ingediend
26 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 augustus 2026
Eerst geplaatst (Werkelijk)
31 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
26 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 26-1724
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Deidentified individual participant data that support the results reported in publications arising from this study will be shared beginning 9 to 36 months following publication, provided that the investigator requesting the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) at Chapel Hill.
When data sharing is permitted, a Data Use Agreement specifying the permitted uses of the shared data must be fully executed before any data are released.
IPD-tijdsbestek voor delen
Data will be available beginning 9 to 36 months following publication of the primary study results and will remain available for a period determined by UNC data-sharing policies and the terms of the applicable Data Use Agreement.
IPD-toegangscriteria voor delen
Investigators seeking access to the data must provide documentation of IRB, IEC, or REB approval, where applicable, and enter into a fully executed Data Use Agreement with the University of North Carolina at Chapel Hill prior to receipt of data.
Requests will be reviewed by the study investigator and the University in accordance with institutional policies.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .