Creatine for Recovery and Thinking in Mothers (CREATE-MOM)
26. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Abbie Smith-Ryan, PhD
- Telefonnummer: 919-962-2574
- E-post: abbiesmith@unc.edu
Studer Kontakt Backup
- Navn: Research Coordinator
- Telefonnummer: 919-962-1663
- E-post: aplresearch@unc.edu
Studiesteder
-
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- Applied Physiology Laboratory
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 919-962-1663
- E-post: aplresearch@unc.edu
-
Hovedetterforsker:
- Abbie Smith-Ryan, PhD
-
-
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
Nei
Beskrivelse
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
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Repeated Sprint Ability Peak Power
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Skeletal Muscle Oxygen Recovery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
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)
8. september 2026
Primær fullføring (Antatt)
10. mai 2027
Studiet fullført (Antatt)
10. mai 2027
Datoer for studieregistrering
Først innsendt
26. august 2026
Først innsendt som oppfylte QC-kriteriene
26. august 2026
Først lagt ut (Faktiske)
31. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-1724
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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