Post-partum, Women
Conditions
Keywords
exercise, creatine monohydrate, post-partum, women's health, recovery, cognition
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.
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.
Interventions
DIETARY_SUPPLEMENTCreatine Monohdyrate
Creatine monohydrate taken daily mixed with 6-8 oz of water.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeated Sprint Ability Peak Power | Change from baseline to 4 weeks post-supplementation. | Peak power (Watts) measured during a repeated sprint ability cycling test. |
| Fatigue Index | Change from baseline to 4 weeks post-supplementation. | Fatigue index (%) calculated from repeated sprint ability testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Muscle Oxygen Recovery | 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. |
| Executive Function | Change from baseline to 4 weeks post-supplementation | Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test. |
| Working Memory | Change in baseline to 4 weeks post-supplementation. | Working memory measured using the NIH Toolbox List Sorting Working Memory Test. |
| Brain Creatine Concentration | 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 |
Countries
United States
Contacts
CONTACTAbbie Smith-Ryan, PhD
CONTACTResearch Coordinator
PRINCIPAL_INVESTIGATORAbbie Smith-Ryan, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed