- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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
|
|
Экспериментальный: 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
|
|
Экспериментальный: 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
|
|
Экспериментальный: 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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Glucose-under-the curve (AUC) after ingestion of 4 types of bread
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Insulin-under-the curve (AUC) after ingestion of 4 types of bread
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Free fatty acid (FFA) AUC after the ingestion of 4 types of bread
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Simona Bo, MD, University of Turin, Italy
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Bo11/14
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