Status:
COMPLETED
Gastrointestinal and Fluid Retention Symptoms Associated With Creatine Monohydrate With and Without Loading Dose Over 28 Days of Supplementation
Lead Sponsor:
Vireo Systems, Inc.
Conditions:
Side Effects of Creatine Monohydrate Dosing
Eligibility:
All Genders
18-60 years
Brief 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.
Detailed Description
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/d...
Eligibility Criteria
Inclusion
- ○ 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
- ○ 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.
Key Trial Info
Start Date :
May 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 3 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07176325
Start Date
May 30 2024
End Date
July 3 2024
Last Update
September 16 2025
Active Locations (1)
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1
Princeton Consumer Research
Raritan, New Jersey, United States, 08869