None listed
Conditions
Brief summary
Creatine monohydrate (CrM) is widely available as a nutritional supplement in Australia that mainly used as an ergogenic aid for sportsmen and women. Pre-clinical studies suggest dietary creatine supplementation during pregnancy may protect the fetus from acute in utero hypoxic events. While there is evidence to support the safety of creatine use in non-pregnant women of reproductive age, there is limited evidence on the pharmacokinetics (PK) of CrM in women of reproductive age and no information on the PK of CrM in pregnancy. To address these knowledge gaps safely, we have designed an open-label parallel-arm pharmacokinetic trial that will occur in three stages; where the first two stages will trial different CrM doses, starting with the lowest anticipated therapeutic dose. The third stage will trial the optimum dose (to be confirmed) over a multi-day period in the third trimester of pregnancy. Overall, This study will inform the optimum dosing of creatine monohydrate in late pregnancy (3rd trimester). This dosing regimen could be used in subsequent studies assessing the efficacy of maternal dietary creatine supplementation to improve pregnancy outcomes.
Interventions
Creatine Monohydrate will be administered orally in a liquid to all participants (pregnant and non-pregnant) by a research midwife after cannulation and collection of baseline samples and observations. The liquid will be consumed within 15 minutes and the time taken to consume the liquid will be recorded. Blood samples will be collected at nine subsequent time points over the course of ten hours post-administration. Subsequent urine samples will be collected at four-time points.
Stage [1]. Part
Creatine Monohydrate will be administered orally in a liquid to all participants (pregnant and non-pregnant) by a research midwife after cannulation and collection of baseline samples and observations. The liquid will be consumed within 15 minutes and the time taken to consume the liquid will be recorded. Blood samples will be collected at nine subsequent time points over the course of ten hours post-administration. Subsequent urine samples will be collected at four-time points. Stage [1]. Participants will receive a 5-gram oral creatine monohydrate as a one-off dose reconstituted from powder and delivered in a suitable beverage for the women. An interim report will be presented to HREC to review the safety and PK profile data from Stage 1. Once the interim report is approved (within a month) Stage 2 will commence. Stage [2]. Participants will receive a 10-gram oral of creatine monohydrate as a one-off dose reconstituted from powder and delivered in a suitable beverage for the women. An interim report will be presented to HREC to review the safety and PK profile data from Stage 2. Once the interim report is approved (within a month) Stage 3 will commence. Stage [3]. This stage of the trial will only involve pregnant women. Participants will receive 4 days of intervention (dose and regimen to be advised after the analysis of Stage 1 and 2 PK profiling). Based on the lag time between stages each stage group will be new participants with no previous exposure to creatine monohydrate.
Sponsors
Monash Medical Centre
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
=/>18 years of age. English speaking and able to give written informed consent No known renal, hepatic, or cardiovascular symptoms. No known gastrointestinal (GIT) disorders affecting absorption from GIT Not consuming known dietary or nutritional supplements containing creatine or protein-based powders BMI <35 Pregnant women only; between 30-34 weeks gestation birthing at the tertiary centre where the trial is being conducted so birthing outcomes can be assessed
Exclusion criteria
<18 years of age Poor English skills or not proficient in reading English Diabetes Type 1 or 2 Known renal disease/hepatic disease Known cardiovascular disease or risk factors for cardiovascular disorders No colitis or any disease affecting absorption and function of the GIT system Taking supplements that may contain creatine or other amino acids BMI >35 Different model of care (not birthing at tertiary centre)
Outcome results
None listed