Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults

The purpose of this study is to compare blood creatine levels following acute oral supplementation of Create Wellness creatine gummies to creatine monohydrate powder.

Study Overview

• Status: Recruiting
• Conditions: Creatine Absorption in Healthy Adults
• Intervention / Treatment: Dietary supplement: Create Wellness Creatine Gummies; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sam R. Moore, PhD; Phone Number: 4053252542; Email: samray@ou.edu

Study Locations

• United States
  • Oklahoma
    • Norman, Oklahoma, United States, 73019
      • Recruiting
      • ATHENA Laboratory
      • Contact: Sam R. Moore, PhD; Phone Number: 405-325-2542; Email: samray@ou.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A (Gummy, Powder)	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.
Experimental: Sequence B (Powder, Gummy)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax)	Maximum plasma concentration observed.	0 to 5-hours following supplementation.
Time to peak plasma concentration (Tmax)	Time to reach maximum plasma concentration.	0 to 5-hours following supplementation.
Area under the curve (AUC)	Area under the plasma concentration curve.	0 to 5-hours following supplementation.

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Sam R Moore, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 19428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No