Effects of a Whole Grain Cereal Product on Blood Glucose Response After 3 Consecutive Meals
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Lund, Suecia
- Aventure AB
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or Female, 35 to 65 years of age
- BMI 22-29 (±0.5) 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 or 2)
- 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, placebo, or standardized meal
- Participants restricted to a vegetarian or vegan diet
- Intolerance to gluten
- Individuals who are averse to 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Comparador de placebos: Reference
|
This intervention is a rice-based breakfast product.
|
|
Comparador activo: Whole grain breakfast product
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This intervention is a whole grain-based breakfast product containing oats and barley.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The difference in capillary blood glucose between whole grain product and reference in the total incremental area under the curve iAUC(0-120 min) for all three meals (Breakfast iAUC0-120 min + Lunch iAUC0-120 min.+ Dinner iAUC0-120 min).
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the breakfast meal.
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products)
|
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products)
|
|
The difference in capillary blood glucose between whole grain product and reference in the 1, 2 and 3-hour incremental area under the curve (iAUC0-60 min, iAUC0-120 min and iAUC0-180 min) after the lunch meal.
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products) and 0-180 min after lunch (standardized meal))
|
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products) and 0-180 min after lunch (standardized meal))
|
|
The difference in capillary blood glucose between whole grain product and reference in the 1 and 2-hour incremental area under the curve (iAUC0-60 min and iAUC0-120 min) after the dinner meal.
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
|
The difference in capillary blood glucose between whole grain product and reference in 2-hour Cmax(0-120 min) (maximum concentration) after the breakfast, lunch and dinner meals respectively.
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
|
The difference in capillary blood glucose between whole grain product and reference in 2-hour Tmax(0-120 min) (the time to maximum concentration) after the breakfast, lunch and dinner meals respectively.
Periodo de tiempo: Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
Outcome measures will be assessed just before and immediately after the intervention (glucose measurements at 0-180 min after breakfast (intervention products), 0-180 min after lunch (standardized meal) and 0-120 min after dinner (standardized meal))
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Kristina Andersson, PhD, Aventure AB
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- TSP2101
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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