- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02650674
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
13 de septiembre de 2017 actualizado por: Mondelēz International, Inc.
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.
It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
12 subjects will be Caucasian and 12 subjects will be Asian.
8 test sessions per subject are included in the study.
Foods are consumed in a random order according to a randomisation list.
The impact of the ethnic group and the products will be determined.
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
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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New South Wales
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Sydney, New South Wales, Australia, 2006
- University of Sydney
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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
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Aged between 18-45 years.
- Non-smoker.
- BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
- Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
- Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
- Healthy subjects with:
Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal resting heart rate (50-90 beats per minutes after 3 minutes rest).
- Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
- Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))
- Able to fast for at least 10 hours the night before each test session.
- Able to refrain from eating legumes and drinking alcohol the day before each test session.
- Subject covered by social security or covered by a similar system
- Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
- Subject having given written consent to take part in the study.
Exclusion Criteria:
- Following a restrictive diet.
- Family history of Diabetes Mellitus or obesity
- Suffering from any clinical, physical or mental illness.
- Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
- Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
- Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
- Subject having taken part in another clinical trial within the last week.
- Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
- Subject undergoing general anaesthesia in the month prior to inclusion.
- Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Product A: NP-0148
Cereal product belVita Milk & Cereals - High in SDS
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Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
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Experimental: Product B: NP-0149
Cereal product belVita Honey & Nuts - High in SDS
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Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
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Experimental: Product C: NP-0150
Cereal product belVita Mixed Berry - High in SDS
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Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
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Experimental: Product D: NP-0151
Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat
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Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
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Experimental: Product E: NP-0152
Cereal product Kellogg's Trésor Duo Choco - Low in SDS
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Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
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Experimental: Glucose reference
Glucose solution performed on three occasions
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Glucose solution providing 50 g of available carbohydrates in 250 ml of water.
This will be performed 3 times
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glycaemic index values of five cereal products
Periodo de tiempo: 2 hours after food consumption
|
Determination of GI in both Caucasian and Asian subjects
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2 hours after food consumption
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Periodo de tiempo: 2 hours after food consumption
|
Determination of GI in the global population
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2 hours after food consumption
|
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Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
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2 hours after food consumption
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Glycaemic response assessed by the peak value of glycemia
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Glycaemic response assessed by the delta value between baseline and peak values of glycemia
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
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2 hours after food consumption
|
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Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
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Insulinaemic response assessed by the peak value of insulinemia
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Insulin / glucose ratio (II/GI) evaluation of five cereal products
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
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Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Kinetic of insulin / glucose over the 120 minutes
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
|
Peak value of insulin / glucose ratio
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
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Delta peak value between baseline and peak values of insulin / glucose ratio
Periodo de tiempo: 2 hours after food consumption
|
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
|
2 hours after food consumption
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennie Brand Miller, University of Sydney
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
1 de octubre de 2015
Finalización primaria (Actual)
1 de marzo de 2016
Finalización del estudio (Actual)
1 de abril de 2016
Fechas de registro del estudio
Enviado por primera vez
30 de octubre de 2015
Primero enviado que cumplió con los criterios de control de calidad
6 de enero de 2016
Publicado por primera vez (Estimar)
8 de enero de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de septiembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2017
Última verificación
1 de septiembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KBE043
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. .