ClinicalTrials.gg
Not yet recruitingNCT07795853CREATE-MOMUpdated Aug 31, 2026

Creatine for Recovery and Thinking in Mothers

An interventional study of Creatine Monohdyrate in Post-partum and Women, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Motor Activity by University of North Carolina, Chapel Hill — 4 open to participants now, 4 under way, none of them phase 3. Motor Activity · University of North Carolina, Chapel Hill.

Planned enrollment
28th of 35
40 · median 78
Started
2026
with 1 other
No phase
34 of 35
4 open now
Registered
35th of 35
by date

Among the 35 studies in Motor Activity by University of North Carolina, Chapel Hill, this one is the 28th largest by planned enrollment, is one of 2 that started in 2026, is one of 34 with no phase, and was the 35th registered.

By phase

35 studies; the count open now beside each. This study's row is marked.

No phasethis study34 · 4 open
Phase 11 · 0 open

By the year they started

First in 2003; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 78 across the 35 interventional studies. Of the 31 that completed or were terminated, 8 (26%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 35 studies in Motor Activity by University of North Carolina, Chapel Hill, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Post-partum
  • Women

Browse trials for

Keywords

  • exercise
  • creatine monohydrate
  • post-partum
  • women's health
  • recovery
  • cognition
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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, , or cancer
  • Currently using medications that may directly impact the primary outcomes including: diuretics and ).
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Low-Dose Creatine Monohydrate

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

    Dietary Supplement: Creatine Monohdyrate

  • Experimental
    High-dose Creatine Monohydrate

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

    Dietary Supplement: Creatine Monohdyrate

Interventions

  • Dietary supplementCreatine Monohdyrate

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

06

What researchers measure

Primary outcomes

  1. Repeated Sprint Ability Peak Power

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

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

  2. Fatigue Index

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

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

Secondary outcomes

  1. Skeletal Muscle Oxygen Recovery

    Recovery rate constant of skeletal muscle oxygen consumption following exercise measured by near-infrared spectroscopy and arterial occlusion procedures.

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

  2. Executive Function

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

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

  3. Working Memory

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

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

  4. Brain Creatine Concentration

    Brain phosphocreatine and related bioenergetic metabolites assessed using phosphorus magnetic resonance spectroscopy (³¹P-MRS) in the imaging subsample

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 8 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 31, 2026
StartEst.
Sep 8, 2026
Primary completionEst.
May 10, 2027
CompletionEst.
May 10, 2027
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07795853
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Sep 8, 2026 (estimated)
Primary completion
May 10, 2027 (estimated)
Completion
May 10, 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Abbie Smith-Ryan, PhD
Contact
abbiesmith@unc.edu
919-962-2574
Research Coordinator
Contact
aplresearch@unc.edu
919-962-1663
Abbie Smith-Ryan, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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