Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Witho… (NCT07176325) | Clinical Trial Compass
CompletedNot Applicable
Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Without Loading Dose Over 28 Days of Supplementation
United States24 participantsStarted 2024-05-30
Plain-language summary
This study aimed to investigate the incidence and severity of GI symptoms associated with daily CM supplementation, with and without a loading phase, in healthy male and female adults.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* â—‹ Subjects must be healthy males or females, aged 18 to 60 inclusive at the time of screening.
* Subjects must be able to understand the study, agree to the requirements and restrictions, and be willing to give voluntary consent to participate in the study.
* Subjects are willing to have up to two (2) blood collections, one at Visit 2 and Visit 3.
* Subjects are willing to provide a urine sample that is collected over 24 hours. This entails collecting all urine in a 24-hour period in a container.
* Subject is willing to fast for 12 hours before the Baseline visit (second visit). Water is permitted.
* Subject is willing to have waist measurements taken with calipers and willing to wear clothing that allows easy access to their waist.
* Female subjects of childbearing potential must agree to one of the following methods of birth control through the duration of the study. Acceptable methods include: abstinence, same-sex partner, double barrier (condom, diaphragm, or cervical cap with spermicidal foam, gel, or cream); intra-uterine device (IUD) with or without hormones in place or hormonal contraception (oral, injectable, implantable, transdermal, or vaginal) used consecutively for at least 3 month prior to screening visit; vasectomized partner or bilateral insertion of Essure® implants (or analogous) for at least 6 months prior to the screening visit; to be considered a female of non- childbearing potential, subject must have had a bilateral t…