The pharmacokinetics and dose response to ingestion of liposomal encapsulated creatine monohydrate in adults

INTERVENTION: The study design will be a double‐blind, randomised, crossover comprising si Xarms in a clinical laboratory setting. This will involve baseline measures plus si Xvisits to the laboratory per participant. Three testing sessions/arms will use the product being tested ‐ liposomal creatine ‐ at different doseages, the remaining three sessions will use creatine monohydrate at equimolar doseages as control. Liposomal creatine consists of creatine monohydrate encapsulated in liposomal components (phosphatidylcholine). Samples will be provided orally, dissolved in water with maltodextrin. Each dose will be given as 300ml of artificially flavoured and coloured water with 1, 2.5, and 5g, respectively. Each session will include: Baseline: Online screening to complete health questionnaire and informed consent. Baseline parameters (personal data, history, anthropometric measures) will be recorded. Instructions and a container for the first baseline 24h urine collection will be provided. Baseline urine will be collected for 24h before each visit. Visit 1: Takes place at least 24‐h after baseline session. Completion of the first arm of the test protocol. ‐ Participants will report to the laboratory after overnight fast between 6‐900h. ‐ Recovery of the 24‐h urine. ‐ Subsequent 24‐h urine collection will start on the onset of the supplement protocol. ‐ Their non‐dominant or hand of choice will be placed in the heat‐hand bo Xand warmed for 20‐30 min. A 21‐23 GA catheter will be placed retrograde (or anterograde as distal as possible if difficulty) in a dorsal hand vein for blood sampling and the line kept patent with slow rate (0.5‐1.0 ml/min) saline drip infusion. ‐ Blood will be collected at time=0 (prior to Creatine supplement ingest CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Musculoskeletal ‐ Normal musculoskeletal and cartilage development and function Sporting Performance; ; Sporting Performance PRIMARY OUTCOME: The primary outcome of the study is the total area under the plasma creatine ‐ time curve. [Per testing session: ; Blood samples will be collected at time=0 (prior to Cr supplement ingestion), and at the following time periods after: 0, 10, 20, 30, 40, 50, 60, 90, 120, 180, 240, 300 min post‐ingestion] INCLUSION CRITERIA: Adults aged 18‐45 with BMI between 18‐30. Participants will be required to pass a Health Screen Questionnaire. SECONDARY OUTCOME: 24h urinary total creatine.[Baseline 24h urine collection will occur in the 24h prior to every testing session. ; Subsequent 24h urine collection will occur starting at the onset of each supplement protocol.] Gut comfort response measured on a gastrointestinal comfort scale. [At baseline and every 30min after ingestion for up to 6 hours post‐ingestion] Peak plasma creatine concentration.[Blood samples collected at time=0 (prior to Cr supplement ingestion), and at the following time periods after: 0, 10, 20, 30, 40, 50, 60, 90, 120, 180, 240, 300 min post‐ingestion] Slope to peak plasma creatine concentration (plotted against time). [Blood samples collected at time=0 (prior to Cr supplement ingestion), and at the following time periods after: 0, 10, 20, 30, 40, 50, 60, 90, 120, 180, 240, 300 min post‐ingestion] Time to peak creatine concentration.[Blood samples collected at time=0 (prior to Cr supplement ingestion), and at the following time periods after: 0, 10, 20, 30, 40, 50, 60, 90, 120, 180, 240, 300 min post‐ingestion]