Cereal-based Products Fortified With Legumes and Effects on Glycemic Control and Appetite Regulation

Study Overview
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Brief Summary
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Legumes are rich source of proteins and dietary fibers which are associated with satiety and amelioration of postprandial glycemic response. The purpose of the study is to examine the effects of cereal-based products fortified with legumes on appetite regulation and body weight management.

Detailed Description
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Postprandial glycemic response as well as response of hormones related to appetite regulation after consumption of cereal-based products fortified with legumes will be evaluated. Apparently healthy subjects with normal body weight and overweight subjects will participate in the study (two protocols). Certain effects on metabolites related to the composition of the different products will be examined. The results of the study will help in the design of a long-term clinical trial regarding the effects of the functional products on body weight management in overweight subjects.

Official Title
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Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management

Conditions
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Appetite

Intervention / Treatment
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* Other: Cereal-legume product 1
* Other: Cereal-legume product 2
* Other: Cereal product
* Other: Reference food


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normal exercise and dietary habits weight stable for at least 3 months before enrollment Exclusion Criteria: pregnancy diabetes chronic medical illness use of nutritional supplements regular intense exercise alcohol consumption >2 drinks per day

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Healthy subjects with normal body weight receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated. Overweight subjects receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cereal-legume product 1<br>Treatment with cereal-legume product-1 | Other: Cereal-legume product 1<br>* The intervention examines the effect of cereal based product fortified with legumes-1 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.<br>|
| Experimental: Cereal-legume product 2<br>Treatment with cereal-legume product-2 | Other: Cereal-legume product 2<br>* The intervention examines the effect of cereal based product fortified with legumes-2 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.<br>|
| Experimental: Cereal product<br>Treatment with cereal product | Other: Cereal product<br>* The intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.<br>|
| Active Comparator: Reference food<br>Treatment with reference food | Other: Reference food<br>* The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose AUC | Change in glucose AUC after consumption of the products compared to the AUC after consumption of the reference food | Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially for each food (totally four times) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cereal-based products fortified with legumes, appetite regulation, postprandial glucose response, postprandial hormone responses