Creatine for Recovery and Thinking in Mothers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
6 weeks -12 months postpartum
Body mass index of 18.5-34.9 kg/m2
Cleared to resume physical activity
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Creatine Monohdyrate
Dietary supplementCreatine monohydrate taken daily mixed with 6-8 oz of water.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Low-Dose Creatine MonohydrateExperimental treatment 1 intervention
Group B: High-dose Creatine MonohydrateExperimental treatment 1 intervention
Trial outcomes
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-supplementation2
Executive Function
Executive function measured using the NIH Toolbox Flanker Inhibitory Control and Attention Test.
Time frame
Change from baseline to 4 weeks post-supplementation3
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-supplementationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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