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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Hyperglycemia, Insulin Sensitivity

Intervention / Treatment
-----------------
* Other: intake of the specific kind of bread


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: commercial bread, wheat flour<br>Intake of the specific kind of bread | Other: intake of the specific kind of bread<br>* 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<br>|
| Experimental: wheat, organic flour<br>Intake of the specific kind of bread | Other: intake of the specific kind of bread<br>* 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<br>|
| Experimental: wheat, supermarket flour<br>Intake of the specific kind of bread | Other: intake of the specific kind of bread<br>* 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<br>|
| Experimental: einkorn, organic flour<br>intake of the specific kind of bread | Other: intake of the specific kind of bread<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose-under-the curve (AUC) after ingestion of 4 types of 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin-under-the curve (AUC) after ingestion of 4 types of 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 |