- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07579455
Acute Pharmacokinetics of Create Wellness Gummies in Healthy Adults
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sam R. Moore, PhD
- Número de teléfono: 4053252542
- Correo electrónico: samray@ou.edu
Ubicaciones de estudio
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Oklahoma
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Norman, Oklahoma, Estados Unidos, 73019
- Reclutamiento
- ATHENA Laboratory
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Contacto:
- Sam R. Moore, PhD
- Número de teléfono: 405-325-2542
- Correo electrónico: samray@ou.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: Sequence B (Powder, Gummy)
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Peak plasma concentration (Cmax)
Periodo de tiempo: 0 to 5-hours following supplementation.
|
Maximum plasma concentration observed.
|
0 to 5-hours following supplementation.
|
|
Time to peak plasma concentration (Tmax)
Periodo de tiempo: 0 to 5-hours following supplementation.
|
Time to reach maximum plasma concentration.
|
0 to 5-hours following supplementation.
|
|
Area under the curve (AUC)
Periodo de tiempo: 0 to 5-hours following supplementation.
|
Area under the plasma concentration curve.
|
0 to 5-hours following supplementation.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sam R Moore, PhD, University of Oklahoma
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 19428
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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