Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response
29 de junio de 2022 actualizado por: Aventure AB
The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response.
The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
17
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Lund, Suecia
- Aventure AB
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
35 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or Female, 35 to 65 years of age
- BMI 18.5-29.9 kg/m2
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- Healthy as determined by medical history and information provided by the volunteer.
- Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
- Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
- Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
- Women who are pregnant or breast feeding
- Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
- Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
- Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
- Use of antibiotics within 2 weeks of enrollment
- Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- Allergy to ingredients included in investigational product, reference, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to venous catheterization or capillary blood sampling
- Currently active smokers (or using other tobacco products, and e-cigarettes)
- Unstable medical conditions as determined by QI
- Participation in other clinical research trials
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Acute infection
Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
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Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Reference
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This intervention is based on white rice.
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Comparador activo: Whole cereal kernels Dose A
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This wholegrain intervention contains whole cereal kernels.
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Comparador activo: Whole cereal kernels Dose B
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This wholegrain intervention contains whole cereal kernels.
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Comparador activo: Cut cereal kernels Dose A
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This wholegrain intervention contains cut cereal kernels.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postprandial capillary blood glucose iAUC (0-120 min)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postprandial capillary blood glucose Cmax
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose Tmax
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting capillary blood glucose
Periodo de tiempo: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting capillary blood glucose the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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Postprandial capillary blood glucose iAUC (0-60 min)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial capillary blood glucose 2-hour iPeak(0-120 min) (incremental maximum value)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in capillary blood glucose between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin iAUC(0-120 min)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin Cmax
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in Cmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial Insulin Tmax
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in Tmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting Insulin
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in fasting venous blood insulin the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial insulin iAUC (0-60 min)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in venous blood insulin between wholegrain products and reference in the 1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Postprandial venous blood insulin 2-hour iPeak(0-120 min) (incremental maximum value)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in venous blood insulin between wholegrain products and reference in the 2-hour iPeak(0-120 min) (incremental maximum value) after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fasting GLP-1
Periodo de tiempo: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting GLP-1 the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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GLP-1 iAUC(0-120 min)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the total incremental area under the curve iAUC(0-120 min) after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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GLP-1 iAUC(0-60 min)
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in the1-hour incremental area under the curve iAUC(0-60 min) after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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GLP-1 Cmax
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The changein GLP-1 between wholegrain products and reference in Cmax after the standardized breakfast meal.
|
Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
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GLP-1 Tmax
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
|
The change in GLP-1 between wholegrain products and reference in Tmax after the standardized breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Fasting PYY
Periodo de tiempo: Outcome measures will be assessed just before the standardized meal is consumed.
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The change in fasting PYY the morning after consuming either wholegrain products or reference.
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Outcome measures will be assessed just before the standardized meal is consumed.
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PYY 2-hour mean concentration
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 2-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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PYY 1-hour mean concentration
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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The change in PYY between the wholegrain products and the reference in the 1-hour mean concentration after the breakfast meal.
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Outcome measures will be assessed just before and immediately after the standardized meal is consumed.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de marzo de 2022
Finalización primaria (Actual)
13 de junio de 2022
Finalización del estudio (Actual)
13 de junio de 2022
Fechas de registro del estudio
Enviado por primera vez
14 de marzo de 2022
Primero enviado que cumplió con los criterios de control de calidad
14 de marzo de 2022
Publicado por primera vez (Actual)
23 de marzo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de julio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- TSP2201
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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