Bread Structure and Postprandial Metabolic Responses

Study Overview
=================
Brief Summary
-----------------
The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with legumes) in comparison with finely milled whole grain bread products on postprandial glycaemic response and appetite regulation.

Detailed Description
-----------------
Postprandial glucose response caused by bread products of different degree of processing, as well as their appetite regulating properties will be evaluated. In the intervention there are totally four samples, the reference (white wheat bread), the less processed whole wheat bread, the whole wheat bread fortified with finely milled legumes (chickpeas), the whole wheat bread fortified with less processed legumes (chickpeas). The volunteers that will be enrolled in the study should be apparently healthy subjects (women and men) with normal body weight. Certain effects related to the structure of the different products on glycemic and insulinemic responses, subjective appetite ratings and other parameters will be examined.

Official Title
-----------------
Effects of Less-processed Whole Grain Bread Products (Wheat and Fortified With Legumes) on Postprandial Glucose and Subsequent Metabolic Responses.

Conditions
-----------------
Postprandial Hyperglycemia

Intervention / Treatment
-----------------
* Other: Finely milled whole wheat-legume bread
* Other: Less processed whole wheat-legume bread
* Other: Less processed whole wheat bread
* Other: White wheat bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal exercise and dietary habbits weight stable for at least 3 months before enrollment Exclusion Criteria: pregnancy and lactation diabetes chronic medical illness regular intense exercise (>5 hrs/week) alcohol consumption >2 drinks/day

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: Finely milled whole wheat-legume bread<br>Treatment with finely milled whole wheat-legume bread. | Other: Finely milled whole wheat-legume bread<br>* The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.<br>|
| Experimental: Less processed whole wheat-legume bread<br>Treatment with less processed whole wheat-legume bread. | Other: Less processed whole wheat-legume bread<br>* The intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight.<br>|
| Experimental: Less processed whole wheat bread<br>Treatment with of less processed whole wheat bread. | Other: Less processed whole wheat bread<br>* The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.<br>|
| Active Comparator: Reference Food (white wheat bread)<br>Treatment with reference food. | Other: White wheat bread<br>* The intervention examines the reference food product in subjects with normal body weight.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food. | Blood glucose concentration will be measured for each participant before and after the test foods, with blood samples being collected at specific time points: 0 (before food consumption), 30, 45, 60, 90, 120, 180 minutes postprandially for each food. | Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings | Subjective evaluation of hunger, satiety, and desire to eat with Visual Analogue Scales, before the consumption and 30, 60, 90, 120, 180 minutes after (0-100 mm with 0 indicating no hunger or perceived ability to consume food/no satiety or no fullness). Difference in perception of these parameters will be measured and compared between the experimental condition and the control condition. | Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially (4 times in total). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bread, food structure, glycemic control, appetite regulation