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

Not Applicable

Completed

• Conditions: Sporting Performance; Diet and Nutrition - Other diet and nutrition disorders; Musculoskeletal - Normal musculoskeletal and cartilage development and function

• Registration Number: ACTRN12623000519651
• Lead Sponsor: Pharmako Biotechnologies Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-19
• Study Completion: 2024-07-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the total area under the plasma creatine - time curve. [ Per testing session: <br>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]