- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
|
|
Experimentální: 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
|
|
Experimentální: 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
|
|
Experimentální: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Glucose-under-the curve (AUC) after ingestion of 4 types of bread
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Insulin-under-the curve (AUC) after ingestion of 4 types of bread
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Free fatty acid (FFA) AUC after the ingestion of 4 types of bread
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Simona Bo, MD, University of Turin, Italy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Bo11/14
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