Creatine for Recovery and Thinking in Mothers

NCT07795853 — Not applicable, Not yet recruiting, 40 participants, University of North Carolina, Chapel Hill

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Creatine for Recovery, Executive Function, Activity, Thinking & Energy in Mothers (CREATE-MOM)

RegistryNCT07795853, acronym CREATE-MOM
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, other
Enrollment40 (Estimated)
SponsorUniversity of North Carolina, Chapel Hill (Other)
ConditionsPost-partum, Women
InterventionsCreatine Monohdyrate (Dietary supplement)
Datesstart 2026-09-08 (estimated), primary completion 2027-05-10 (estimated), completion 2027-05-10 (estimated), first posted 2026-08-31, last updated 2026-08-31
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Post-partum All trials for Women All trials of Creatine Monohdyrate

-Summary

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.

Expand all sections  ·  Collapse all

+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Low-Dose Creatine MonohydrateExperimentalDietary Supplement: Creatine MonohdyrateParticipants consume 5 grams per day of creatine monohydrate for 28 consecutive days.
High-dose Creatine MonohydrateExperimentalDietary Supplement: Creatine MonohdyrateParticipants consume 10 grams per day of creatine monohydrate for 28 consecutive days.
  • Creatine Monohdyrate (Dietary supplement): Creatine monohydrate taken daily mixed with 6-8 oz of water.

+Outcome measures

Primary outcomes

  • Repeated Sprint Ability Peak Power [Change from baseline to 4 weeks post-supplementation.]: Peak power (Watts) measured during a repeated sprint ability cycling test.
  • Fatigue Index [Change from baseline to 4 weeks post-supplementation.]: Fatigue index (%) calculated from repeated sprint ability testing.

Secondary outcomes

  • Skeletal Muscle Oxygen Recovery [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.
  • Executive Function [Change from baseline to 4 weeks post-supplementation]: Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.
  • Working Memory [Change in baseline to 4 weeks post-supplementation.]: Working memory measured using the NIH Toolbox List Sorting Working Memory Test.
  • Brain Creatine Concentration [Change from baseline to 4 weeks post-supplementation]: Brain phosphocreatine and related bioenergetic metabolites assessed using phosphorus magnetic resonance spectroscopy (³¹P-MRS) in the imaging subsample

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

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

+Locations (1)

FacilityCityCountryStatus
Applied Physiology LaboratoryChapel Hill, North CarolinaUnited States

+Investigators