Health TrialsbyHealthPanel

Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults

ConditionCreatine Absorption in Healthy Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Oklahoma

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Create Wellness Creatine Gummies

    Dietary supplement

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

  • Creatine Monohydrate Powder

    Dietary supplement

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

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Sequence A (Gummy, Powder)Experimental treatment 2 interventions
Group B: Sequence B (Powder, Gummy)Experimental treatment 2 interventions

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Source ClinicalTrials.gov
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