None listed
Conditions
Brief summary
The purpose of the LipoCre study is to investigate the digestibility and bioavailability of liposomal creatine. Creatine is used as a sports supplement and in some other applications. Creatine is a naturally occurring compound found in foods like fish and meat that provides energy for rapid, powerful short burst maximal efforts in sports. The most common form of creatine used in supplements is creatine monohydrate (CrM), which can enhance high-intensity performance and training adaptations in various sports. CrM supplementation may also have potential benefits for brain health and function in tasks requiring memory and performing challenging tasks, diabetes, immunity, vascular and heart health, cancer, post-viral fatigue, and exercise capacity in children with muscular dystrophy. However, one of the reported side-effects of 5 g doses of CrM is gut discomfort for an hour or two after ingestion. To address this issue, a recent innovation has been to wrap up CrM into liposomal vesicles, which are small lipid packages, to increase and speed absorption by the gut. The LipoCre study aims to investigate whether liposomal creatine provides greater benefits to delivery of creatine into the body, compared to creatine monohydrate, which may lead to further research into possible benefits for sports performance and some aspects of health. The design is a 6-arm randomized crossover conducted in 12 adults aged 18 to 65 y. In each arm of the study, the absorption kinetics of 3 doses of LCr (1, 2.5, and 5 g) will be compared to the same 3 doses of CrM. The identity of each treatment will be hidden to both the participants and researchers, with the code held by a third party. In total, participants will come to the lab 7 times: 1 for introduction and 6 times for each arm of the study, representing the test day. In addition, they will collect all urine for the 24h prior to the test day, overnight, during, and again overnight up to the morning upon waking the day following. Testing will consist of blood being collected from a hand-vein at regular intervals for 5.5 hours after creatine ingestion. Additionally, gut comfort will be measured at regular intervals on a linear scale. Participants will remain rested either fully or semi reclined on a research bed or chair during sampling and may do (1-handed) computer work, watch TV or relax. Blood plasma be stored and later analyzed for Cr concentration using mass spectrometry at Massey University. Data will be analyzed to determine how much of and how fast the Cr has been absorbed. Results will be used to inform upon the dose strategy to be applied to studies on muscle and performance and possibly brain and cognitive function with the LCr product.
Interventions
The study design will be a double-blind, randomised, crossover comprising six arms in a clinical laboratory setting. This will involve baseline measures plus six visits 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 (phosp
The study design will be a double-blind, randomised, crossover comprising six arms in a clinical laboratory setting. This will involve baseline measures plus six visits 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 box and 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 ingestion), and at the following time periods after: 0, 10, 20, 30, 40, 50, 60, 90, 120, 180, 240, 300 min. - After baseline blood sample is taken, participants will be given a pre-mixed solution containing the supplement, and supervised by the researcher as they consume it in as short a time as possible. - At baseline and every 30 min a gastrointestinal comfort scale will be completed by the participants. Visits 2-6: Will be separated by at least 7 days washout and will be repeats of visit 1 but with a different test supplement. The test supplement will be provided in randomized order presentation.
Sponsors
Pharmako Biotechnologies Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Adults aged 18-45 with BMI between 18-30. Participants will be required to pass a Health Screen Questionnaire.
Exclusion criteria
• Failure to meet health requirements defined in the Health Questionnaire • Known bleeding disorder or blood borne disease • Gastrointestinal (e.g., cancer, celiac, irritable bowel) or metabolic (e.g., diabetes, hyperthyroid) disease • Taking medications thought to interfere with the study outcomes • Currently participating or having participated in another clinical study during the last four weeks prior to the beginning of this study that may affect results • Habitual creatine user or planning on starting supplementation during course of the study • Recent change in high dietary creatine-containing food (meat, fish) intake or plan to change dietary pattern during participation in the study • Oligomenorrhea or amenorrhea in women • Currently on hormonal contraceptives including hormonal contracetive pills, hormonal IUD (including Mirena and Jaydess), hormonal injection (such as Depo Provera), or hormonal implant (such as rods) • Unable to meet study requirements Women will be asked to book testing sessions between days 3-8 of their cycle.
Outcome results
None listed