Creatine for Recovery and Thinking in Mothers

NCT07795853 | Not Yet Recruiting

• 1 other identifier: 26-1724
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-partum; Women

Keywords

exercise; creatine monohydrate; post-partum; women's health; recovery; cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Skeletal Muscle Oxygen Recovery

  Change from baseline to 4 weeks post-supplementation

• Executive Function

  Change from baseline to 4 weeks post-supplementation

• Working Memory

  Change in baseline to 4 weeks post-supplementation.

• Brain Creatine Concentration

  Change from baseline to 4 weeks post-supplementation

Study Arms (2)

Low-Dose Creatine Monohydrate

EXPERIMENTAL

Participants consume 5 grams per day of creatine monohydrate for 28 consecutive days.

Dietary Supplement: Creatine Monohdyrate

High-dose Creatine Monohydrate

EXPERIMENTAL

Participants consume 10 grams per day of creatine monohydrate for 28 consecutive days.

Dietary Supplement: Creatine Monohdyrate

Interventions

Creatine Monohdyrate DIETARY_SUPPLEMENT

Creatine monohydrate taken daily mixed with 6-8 oz of water.

High-dose Creatine Monohydrate; Low-Dose Creatine Monohydrate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• weeks -12 months postpartum
• Body mass index of 18.5-34.9 kg/m2
• Cleared to resume physical activity

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abbie Smith-Ryan, PhD

CONTACT

919-962-2574; abbiesmith@unc.edu

Research Coordinator

CONTACT

919-962-1663; aplresearch@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either 5 g/day or 10 g/day creatine monohydrate for four weeks.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 8, 2026
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)