Post-partumCREATE-MOMNCT07795853
Creatine for Recovery and Thinking in Mothers
A study testing Creatine Monohdyrate in people with Post-partum and Women, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post-partum, Women
- What is being tested?
- Creatine Monohdyrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2026to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 6 weeks -12 months postpartum
- Body mass index of 18.5-34.9 kg/m2
- Cleared to resume physical activity
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27599
Study Coordinator, 919-962-1663, aplresearch@unc.edu
Abbie Smith-Ryan, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-partum, Women
- Being tested
- Creatine Monohdyrate
- Keywords
- exercise, creatine monohydrate, post-partum, women's health, recovery, cognition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine MonohdyrateDietary supplement
Creatine monohydrate taken daily mixed with 6-8 oz of water.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Creatine Monohydrate | Experimental | Participants consume 5 grams per day of creatine monohydrate for 28 consecutive days. Receives: Dietary Supplement: Creatine Monohdyrate |
| High-dose Creatine Monohydrate | Experimental | Participants consume 10 grams per day of creatine monohydrate for 28 consecutive days. Receives: Dietary Supplement: Creatine Monohdyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated Sprint Ability Peak Power
Peak power (Watts) measured during a repeated sprint ability cycling test.
Measured: Change from baseline to 4 weeks post-supplementation.
Fatigue Index
Fatigue index (%) calculated from repeated sprint ability testing.
Measured: Change from baseline to 4 weeks post-supplementation.
Secondary outcomes (4)
Skeletal Muscle Oxygen Recovery
Recovery rate constant of skeletal muscle oxygen consumption following exercise measured by near-infrared spectroscopy and arterial occlusion procedures.
Measured: Change from baseline to 4 weeks post-supplementation
Executive Function
Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.
Measured: Change from baseline to 4 weeks post-supplementation
Working Memory
Working memory measured using the NIH Toolbox List Sorting Working Memory Test.
Measured: 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
Measured: Change from baseline to 4 weeks post-supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start8 Sep 2026 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-partumStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either 5 g/day or 10 g/day creatine monohydrate for four weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795853
- Sponsor's protocol ID
- 26-1724
- Acronym
- CREATE-MOM
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine for Recovery, Executive Function, Activity, Thinking & Energy in Mothers (CREATE-MOM)
- ClinicalTrials.gov ID
- NCT07795853
- Acronym / sponsor ID
- CREATE-MOM / 26-1724
- Conditions
- Post-partum, Women
- Keywords
- exercise, creatine monohydrate, post-partum, women's health, recovery, cognition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either 5 g/day or 10 g/day creatine monohydrate for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Creatine Monohydrate | Experimental | Dietary Supplement: Creatine MonohdyrateParticipants consume 5 grams per day of creatine monohydrate for 28 consecutive days. |
| High-dose Creatine Monohydrate | Experimental | Dietary Supplement: Creatine MonohdyrateParticipants consume 10 grams per day of creatine monohydrate for 28 consecutive days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 6 weeks -12 months postpartum
- Body mass index of 18.5-34.9 kg/m2
- Cleared to resume physical activity
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine MonohdyrateCreatine monohydrate taken daily mixed with 6-8 oz of water. | Dietary supplement | High-dose Creatine Monohydrate, Low-Dose Creatine Monohydrate |
Primary outcome
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.
Fatigue Index
Time frame: Change from baseline to 4 weeks post-supplementation.
Fatigue index (%) calculated from repeated sprint ability testing.
4 secondary outcomes
Skeletal Muscle Oxygen Recovery
Time frame: Change from baseline to 4 weeks post-supplementation
Executive Function
Time frame: Change from baseline to 4 weeks post-supplementation
Working Memory
Time frame: Change in baseline to 4 weeks post-supplementation.
Brain Creatine Concentration
Time frame: Change from baseline to 4 weeks post-supplementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abbie Smith-Ryan, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine Monohdyrate in people with Post-partum and Women, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abbie Smith-Ryan, PhD (919-962-2574, abbiesmith@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeated Sprint Ability Peak Power (time frame: Change from baseline to 4 weeks post-supplementation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.