Creatine for Recovery and Thinking in Mothers (CREATE-MOM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Women; Post-partum
• Intervention / Treatment: Dietary supplement: Creatine Monohdyrate

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abbie Smith-Ryan, PhD; Phone Number: 919-962-2574; Email: abbiesmith@unc.edu
• Study Contact Backup: Name: Research Coordinator; Phone Number: 919-962-1663; Email: aplresearch@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Applied Physiology Laboratory
      • Contact: Study Coordinator; Phone Number: 919-962-1663; Email: aplresearch@unc.edu
      • Principal Investigator: Abbie Smith-Ryan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Dose Creatine Monohydrate; Participants consume 5 grams per day of creatine monohydrate for 28 consecutive days.	Dietary supplement: Creatine Monohdyrate; Creatine monohydrate taken daily mixed with 6-8 oz of water.
Experimental: High-dose Creatine Monohydrate; Participants consume 10 grams per day of creatine monohydrate for 28 consecutive days.	Dietary supplement: Creatine Monohdyrate; Creatine monohydrate taken daily mixed with 6-8 oz of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeated Sprint Ability Peak Power	Peak power (Watts) measured during a repeated sprint ability cycling test.	Change from baseline to 4 weeks post-supplementation.
Fatigue Index	Fatigue index (%) calculated from repeated sprint ability testing.	Change from baseline to 4 weeks post-supplementation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal Muscle Oxygen Recovery	Recovery rate constant of skeletal muscle oxygen consumption following exercise measured by near-infrared spectroscopy and arterial occlusion procedures.	Change from baseline to 4 weeks post-supplementation
Executive Function	Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.	Change from baseline to 4 weeks post-supplementation
Working Memory	Working memory measured using the NIH Toolbox List Sorting Working Memory Test.	Change in baseline to 4 weeks post-supplementation.
Brain Creatine Concentration	Brain phosphocreatine and related bioenergetic metabolites assessed using phosphorus magnetic resonance spectroscopy (³¹P-MRS) in the imaging subsample	Change from baseline to 4 weeks post-supplementation

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Estimated): September 8, 2026
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 31, 2026

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: exercise; cognition; recovery; women's health; creatine monohydrate; post-partum
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 26-1724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 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 Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No