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NCT Number: NCT07795853

Creatine for Recovery and Thinking in Mothers

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location contact

Abbie Smith-Ryan, PhD

PRINCIPAL_INVESTIGATOR

Study Coordinator

CONTACT

[email protected]

919-962-1663

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine Monohdyrate

Dietary Supplement

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

Primary outcomes

  1. Repeated Sprint Ability Peak Power

    Time frame: Change from baseline to 4 weeks post-supplementation.

    Peak power (Watts) measured during a repeated sprint ability cycling test.

  2. Fatigue Index

    Time frame: Change from baseline to 4 weeks post-supplementation.

    Fatigue index (%) calculated from repeated sprint ability testing.

Secondary outcomes

  1. Skeletal Muscle Oxygen Recovery

    Time frame: 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.

  2. Executive Function

    Time frame: Change from baseline to 4 weeks post-supplementation

    Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.

  3. Working Memory

    Time frame: Change in baseline to 4 weeks post-supplementation.

    Working memory measured using the NIH Toolbox List Sorting Working Memory Test.

  4. Brain Creatine Concentration

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Abbie Smith-Ryan, PhD

CONTACT

[email protected]

919-962-2574

Research Coordinator

CONTACT

[email protected]

919-962-1663

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: CREATE-MOM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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