Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Without Loading Dose Over 28 Days of Supplementation

In a 28-day single-center, single-blind, randomized clinical trial, 24 healthy participants were assigned to either Group A (5 g/day CM) or Group B (20 g/day loading dose for 14 days followed by 5 g/day maintenance). Blood and urine samples were collected at baseline and day 28 to assess safety. GI symptoms were recorded via self-report using a structured severity rating scale.

Inclusion criteria

• ○ 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 tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal status with amenorrhea (no menstruation) for at least 1 year prior to the screening visit.
• Subject is willing to comply with the study restrictions.
• Subjects is willing to maintain their current exercise regimen and their current diet while on the study.

Exclusion criteria

• ○ Subjects who are participating in another Clinical Trial.

• Subjects who faint during blood collection, or who have a phobia of needles, or a phobia of blood.
• Subjects who are weightlifters.
• Females who are pregnant or lactating (verbal confirmation only).
• Subject who has taken any creatine supplements in the last 30 days.
• Subjects with history of cancer (except localized skin cancer without metastases) within 5 years prior to the screening visit.
• Subject has diabetes (insulin dependent or not) or any immune deficiency disease such as HIV/AIDS, etc.
• Subject has any medical condition whether treating with mediation or not including hypertension (high blood pressure), hepatitis, any kidney disease or disorders, or musculoskeletal disorders. Note: if there are any significantly abnormal results for the BUN/creatinine screening labs the subject will be dropped.
• Subject is taking a medication that would preclude participation in the study per the Principal Investigator.
• Subjects with recent or current medical condition that may significantly impact the subject or the validity of the study results in the opinion of the Investigator.
• Subjects who have a known or suspected allergy or sensitivity to creatine.
• Chronic use of NSAIDs (e.g., Ibuprofen, Advil), or use of NSAIDs at one-week prior to each study visit.