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Glycemic and Hormone Responses After the Intake of Four Types of Bread.

10 de enero de 2016 actualizado por: Simona Bo, University of Turin, Italy

Glycemic and Hormone Responses and Satiety After the Intake of Four Types of Bread.

The purposes of the present study are to determine the glycemic and insulinemic responses, the satiety rate and the postprandial plasma concentrations of free fatty acids, triglycerides and satiety hormones after the ingestion of four types of breads: handcrafted bread made with wheat organic flour; handcrafted bread with wheat flour of large-scale retail distribution; handcrafted bread with organic einkorn flour and a commercial wheat bread.

Descripción general del estudio

Estado

Terminado

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

Intervencionista

Inscripción (Actual)

16

Fase

  • No aplica

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

20 años a 50 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

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

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: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Simona Bo, MD, University of Turin, Italy

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 febrero de 2015

Finalización primaria (Actual)

1 de julio de 2015

Finalización del estudio (Actual)

1 de julio de 2015

Fechas de registro del estudio

Enviado por primera vez

6 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

10 de enero de 2016

Publicado por primera vez (Estimar)

12 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de enero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

10 de enero de 2016

Última verificación

1 de enero de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Bo11/14

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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