Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Sam R. Moore, PhD
- Telefonnummer: 4053252542
- E-mail: samray@ou.edu
Studiesteder
-
-
Oklahoma
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Norman, Oklahoma, Forenede Stater, 73019
- Rekruttering
- ATHENA Laboratory
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Kontakt:
- Sam R. Moore, PhD
- Telefonnummer: 405-325-2542
- E-mail: samray@ou.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sequence A (Gummy, Powder)
|
Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size.
4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.
|
|
Eksperimentel: Sequence B (Powder, Gummy)
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Create Wellness creatine gummies provide 4.5 grams of creatine monohydrate in a 3 gummy serving size.
4.5 grams of creatine monohydrate powder (Creapure®) dissolved in 240 mL of water.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak plasma concentration (Cmax)
Tidsramme: 0 to 5-hours following supplementation.
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Maximum plasma concentration observed.
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0 to 5-hours following supplementation.
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Time to peak plasma concentration (Tmax)
Tidsramme: 0 to 5-hours following supplementation.
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Time to reach maximum plasma concentration.
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0 to 5-hours following supplementation.
|
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Area under the curve (AUC)
Tidsramme: 0 to 5-hours following supplementation.
|
Area under the plasma concentration curve.
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0 to 5-hours following supplementation.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sam R Moore, PhD, University of Oklahoma
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 19428
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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