Creatine Absorption in Healthy AdultsNCT07579455
Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults
A study testing Create Wellness Creatine Gummies and Creatine Monohydrate Powder in people with Creatine Absorption in Healthy Adults, run by University of Oklahoma at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Creatine Absorption in Healthy Adults
- What is being tested?
- Create Wellness Creatine Gummies and Creatine Monohydrate Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ATHENA Laboratory
Norman, Oklahoma, 73019
Sam R. Moore, PhD, 405-325-2542, samray@ou.edu
About this study
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.
- Conditions
- Creatine Absorption in Healthy Adults
- Being tested
- Create Wellness Creatine Gummies, Creatine Monohydrate Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Create Wellness Creatine GummiesDietary supplement
Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size.
Creatine Monohydrate PowderDietary supplement
4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (Gummy, Powder) | Experimental | Not described Receives: Dietary Supplement: Create Wellness Creatine Gummies; Dietary Supplement: Creatine Monohydrate Powder |
| Sequence B (Powder, Gummy) | Experimental | Not described Receives: Dietary Supplement: Create Wellness Creatine Gummies; Dietary Supplement: Creatine Monohydrate Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax)
Maximum plasma concentration observed.
Measured: 0 to 5-hours following supplementation.
Time to peak plasma concentration (Tmax)
Time to reach maximum plasma concentration.
Measured: 0 to 5-hours following supplementation.
Area under the curve (AUC)
Area under the plasma concentration curve.
Measured: 0 to 5-hours following supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Creatine Absorption in Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over design where participants will be randomized to order (gummy, powder) and complete both treatments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam R Moore, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579455
- Sponsor's protocol ID
- 19428
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults
- ClinicalTrials.gov ID
- NCT07579455
- Acronym / sponsor ID
- 19428
- Conditions
- Creatine Absorption in Healthy Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, cross-over design where participants will be randomized to order (gummy, powder) and complete both treatments.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Create Wellness Creatine GummiesCreate Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size. | Dietary supplement | Sequence A (Gummy, Powder), Sequence B (Powder, Gummy) |
| Creatine Monohydrate Powder4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water. | Dietary supplement | Sequence A (Gummy, Powder), Sequence B (Powder, Gummy) |
Primary outcome
Peak plasma concentration (Cmax)
Time frame: 0 to 5-hours following supplementation.
Maximum plasma concentration observed.
Time to peak plasma concentration (Tmax)
Time frame: 0 to 5-hours following supplementation.
Time to reach maximum plasma concentration.
Area under the curve (AUC)
Time frame: 0 to 5-hours following supplementation.
Area under the plasma concentration curve.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam R Moore, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Create Wellness Creatine Gummies and Creatine Monohydrate Powder in people with Creatine Absorption in Healthy Adults, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sam R. Moore, PhD (4053252542, samray@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration (Cmax) (time frame: 0 to 5-hours following supplementation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.