Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults

NCT07579455 | Not Yet Recruiting

• 1 other identifier: 19428
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Creatine Absorption in Healthy Adults

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Sequence A (Gummy, Powder)

EXPERIMENTAL

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

Sequence B (Powder, Gummy)

EXPERIMENTAL

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

Interventions

Create Wellness Creatine Gummies DIETARY_SUPPLEMENT

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

Sequence A (Gummy, Powder); Sequence B (Powder, Gummy)

Creatine Monohydrate Powder DIETARY_SUPPLEMENT

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

Sequence A (Gummy, Powder); Sequence B (Powder, Gummy)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

ATHENA Laboratory

Norman, Oklahoma, 73019, United States

Location

Study Officials

• Sam R Moore, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam R. Moore, PhD

CONTACT

4053252542; samray@ou.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, cross-over design where participants will be randomized to order (gummy, powder) and complete both treatments.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)