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RecruitingNCT07579455Updated May 28, 2026

Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults

An interventional study of Create Wellness Creatine Gummies and Creatine Monohydrate Powder in Creatine Absorption in Healthy Adults, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Creatine Absorption in Healthy Adults
03

In context

Lead sponsor

University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Sequence A (Gummy, Powder)

    Dietary Supplement: Create Wellness Creatine Gummies · Dietary Supplement: Creatine Monohydrate Powder

  • Experimental
    Sequence B (Powder, Gummy)

    Dietary Supplement: Create Wellness Creatine Gummies · Dietary Supplement: Creatine Monohydrate Powder

Interventions

  • Dietary supplementCreate Wellness Creatine Gummies

    Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size.

  • Dietary supplementCreatine Monohydrate Powder

    4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.

06

What researchers measure

Primary outcomes

  1. Peak plasma concentration (Cmax)

    Maximum plasma concentration observed.

    Time frame: 0 to 5-hours following supplementation.

  2. Time to peak plasma concentration (Tmax)

    Time to reach maximum plasma concentration.

    Time frame: 0 to 5-hours following supplementation.

  3. Area under the curve (AUC)

    Area under the plasma concentration curve.

    Time frame: 0 to 5-hours following supplementation.

07

Study locations

1 of 1 sites recruiting
  • ATHENA Laboratory
    Norman, Oklahoma 73019, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07579455
Lead sponsor
University of Oklahoma
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Jun 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 28, 2026

Study contacts

Sam R. Moore, PhD
Contact
samray@ou.edu
4053252542
Sam R Moore, PhD
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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