Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit

Study Overview
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Brief Summary
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Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.

Detailed Description
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Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack. At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.

Official Title
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Glucose and Gastrointestinal Hormone Responses of Subjects With Overweight/Obesity After 12-week Hypocaloric Dietary Intervention Supplemented With a Cereal-based Biscuit Enriched With Plant Proteins

Conditions
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Appetite

Intervention / Treatment
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* Other: wheat biscuit enriched with plant proteins
* Other: common wheat biscuit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-diabetic women with overweight/obesity constant body weight for the last three months before enrollment standard dietary and physical activity habits Exclusion Criteria: pregnancy lactation chronic medical illness use of nutritional supplements alcohol consumption >2 drinks per day

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

Sexes Eligible for Study
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Female

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wheat-based biscuit enriched with plant proteins<br>Subjects follow a hypocaloric dietary intervention supplemented with certain amount of wheat-based biscuits enriched with plant proteins daily. | Other: wheat biscuit enriched with plant proteins<br>* Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a biscuit enriched with plant proteins<br>|
| Active Comparator: wheat biscuit<br>Subjects follow a hypocaloric dietary intervention supplemented with certain isocaloric amount of common wheat biscuits daily. | Other: common wheat biscuit<br>* Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a common wheat biscuit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in postprandial glucose response | change in glucose iAUC and glucose concentration at certain time points at the end of the dietary intervention compared to the beginning. | Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in postprandial appetite regulating hormone responses | changes in iAUCs and concentrations at certain time points at the end of the dietary intervention compared to the beginning. | Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cereal-based biscuit enriched with plant proteins, appetite regulation, glycemic control, hormone responses