- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02653677
Glycemic and Hormone Responses After the Intake of Four Types of Bread.
Glycemic and Hormone Responses and Satiety After the Intake of Four Types of Bread.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The postprandial blood glucose concentration appears to play a critical role in the development of diabetes and cardiovascular diseases; it is largely influenced by the carbohydrate load of a meal. Thus, advocating carbohydrate (CHO) foods that promote favorable glycemic and insulinemic responses, with maintenance of satiety high over a longer period, may be a beneficial approach against many chronic diseases.
Bread is a basic food in Italian feeding. The industrial production of bread is gradually replacing the craft production by small bakeries. It is possible to buy daily bread obtained by completing baking carried out directly at the point of sale from pre-cooked and frozen dough. The use of "improver" as enzyme preparations such as alpha-amylase, improves the quality of bread. A study has found that trestatin, an amylase inhibitor incorporated into bread, produced lower glycemic and insulinemic responses; another has reported that bread made from the ancient wheat Einkorn (Triticum monococcum) elicited a reduced production of glucose-dependent insulinotrophic polypeptide (GIP).
The objectives of the present study are to determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available CHO:
- 97 g handcrafted bread made with wheat organic flour;
- 97 g handcrafted bread with wheat flour of large-scale retail distribution;
- 94 g handcrafted bread with organic einkorn flour
86 g commercial precooked-frozen white bread.
16 healthy volunteers participated to this randomized cross-over trial. Each participant consumed the specific portion of a type of bread in the morning, after 8-12 h fasting. The other 3 types of bread are consumed by participants in the order determined by the randomization procedure, after a week each other.
At enrollment, all participants meet the inclusion criteria (see below). Nutrition and exercise advices are given for the day before each bread test. Participants should consume the bread portion in 15 minutes.
Blood samples are drawn every 30-min from fasting until 120-min after bread consumption. The following variables are evaluated at each time point: glucose, insulin, FFA, triglycerides, acylated ghrelin. The satiety rate is estimated every 30-min by the Satiety Labeled Intensity Magnitude scales.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- body mass index (BMI) between 18 and 25 kg/m2
- healthy
- Accept to participate in the study
Exclusion Criteria:
- smokers
- subjects suffering from any diseases
- drug therapy
- dietary supplementation
- patients unable to give informed consent to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: commercial bread, wheat flour
Intake of the specific kind of bread
|
To determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates
|
|
Experimental: wheat, organic flour
Intake of the specific kind of bread
|
To determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates
|
|
Experimental: wheat, supermarket flour
Intake of the specific kind of bread
|
To determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates
|
|
Experimental: einkorn, organic flour
intake of the specific kind of bread
|
To determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glucose-under-the curve (AUC) after ingestion of 4 types of bread
Periodo de tiempo: 0 to 120 minutes after the ingestion of each bread
|
Glycemic AUC is defined as the blood glucose increment over 2 hours in response to the consumption of the amount of bread providing 50 g of available carbohydrates
|
0 to 120 minutes after the ingestion of each bread
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insulin-under-the curve (AUC) after ingestion of 4 types of bread
Periodo de tiempo: 0 to 120 minutes after the ingestion of each bread
|
Insulinemic AUC is defined as the blood insulin increment over 2 hours in response to the consumption of the amount of bread providing 50 g of available carbohydrates
|
0 to 120 minutes after the ingestion of each bread
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Free fatty acid (FFA) AUC after the ingestion of 4 types of bread
Periodo de tiempo: 0 to 120 minutes after the ingestion of each bread
|
FFA AUC is defined as the variation in FFA concentrations in response to the consumption of the amount of bread providing 50 g of available carbohydrates
|
0 to 120 minutes after the ingestion of each bread
|
|
Ghrelin responses after the ingestion of 4 types of bread
Periodo de tiempo: 0 to 120 minutes after the ingestion of each bread
|
Ghrelin AUC is defined as the variation in ghrelin concentrations in response to the consumption of the amount of bread providing 50 g of available carbohydrates
|
0 to 120 minutes after the ingestion of each bread
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Simona Bo, MD, University of Turin, Italy
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Bo11/14
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