Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Create Wellness Creatine Gummies, Creatine Monohydrate Powder.
- Who it may be relevant to
- Registry conditions: Creatine Absorption in Healthy Adults. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to compare blood creatine levels following acute oral supplementation of Create Wellness creatine gummies to creatine monohydrate powder.
Detailed description
To examine and compare acute effects of Create Wellness creatine gummies and creatine monohydrate powder on blood creatine levels.
Prior to the baseline visit, each participant will be sent an electronic version of the informed consent to review participation details. Those interested will complete a phone screening for inclusion/exclusion criteria. If the participant qualifies for the study and is interested in participating, verbal consent will be obtained. An electronic link for written consent and a self-reported medical health history questionnaire will be sent after verbal consent. Each participant will provide electronic written informed consent and complete the health/medical history questionnaire. Following written electronic consent, health history will be reviewed by the research team to confirm eligibility.
Visits 1 \& 2: Participants will be asked to arrive to the laboratory after an 8-hour overnight fast from caloric foods and beverages and having abstained from vigorous exercise, caffeine, alcohol, and tobacco for the previous 24-hours. Anthropometrics (height and weight) and body composition (via multi-frequency bioelectrical impedance analysis) will be obtained upon arrival and a urine sample will be collected to determine acute hydration and pregnancy status for female participants. Blood samples will then be obtained from the antecubital region at baseline and 30-min, 1-hour, 2-hours, 3-hours, 4-hours, and 5-hours following oral ingestion of the assigned supplement. Participants will be randomized to supplement order of Create Wellness creatine gummies (3 gummies, 4.5 grams of creatine monohydrate) or creatine monohydrate powder (4.5 grams creatine monohydrate in 240 mL water). Gastrointestinal surveys will be also be collected. All research visits will take place at the ATHENA Laboratory in the Health and Exercise Science Department at the University of Oklahoma, Norman Campus. All data will be collected by the Principal Investigator and ATHENA Laboratory Research Assistants.
Interventions
- Dietary supplement Create Wellness Creatine Gummies
Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size. - Dietary supplement Creatine Monohydrate Powder
4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.
Primary outcome measures
- Peak plasma concentration (Cmax) [Time frame: 0 to 5-hours following supplementation.]
- Time to peak plasma concentration (Tmax) [Time frame: 0 to 5-hours following supplementation.]
- Area under the curve (AUC) [Time frame: 0 to 5-hours following supplementation.]
Eligibility criteria
Inclusion criteria
- Adults between the ages of 18-45 yrs
- Body mass index of <35 kg/m2
- Recreationally active \[(≥30 minutes of moderate-intensity physical activity per week as defined by the International Physical Activity Questionnaire (IPAQ)\]
- Healthy and free from major diseases as determined from screening call and health history questionnaire.
- Agrees to complete pre-assessment guidelines (8-hour fast from caloric foods and beverages, 24-hour abstention from vigorous physical activity, caffeine, alcohol, and tobacco).
Exclusion criteria
- Chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer.
- Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids).
- Currently using creatine monohydrate
- Severely impaired hearing or speech or inability to speak English.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- ATHENA Laboratory — Norman
Identifiers
NCT: NCT07579455 · 19428