Metabolic Response to the Acute Consumption of Fiber-enriched Pasta

Study Overview
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Brief Summary
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Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. The diet, with its pleiotropic effects, is one of the most effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers have been extensively studied and the available evidence supports the beneficial effects of its consumption. However, worldwide the average fiber consumption is still less than the recommended daily dose. For this reason, the availability of functional foods, such as additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.

Official Title
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Effects of the Consumption of Fiber-enriched Pasta on Glucose and Lipid Metabolism and Satiety

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Test meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18-29 kg / m2 Good Health status Exclusion Criteria: Diabetes Cardiovascular events (IMA or stroke) severe heart disease Kidney or liver failure Anemia and any other chronic disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber-enriched pasta<br>The participants consume whole wheat pasta with added fiber (fiber 12 g fiber/100 g). | Other: Test meal<br>* The two test meals are designed to have the same energy and macronutrient composition. They differ only in the carbohydrate source: fiber-enriched pasta or control pasta. Blood samples are taken at fasting and every 30 minutes over 4 hours. Fasting and postprandial intestinal fermentation is evaluated by breath test.<br>* Other names: Acute test meal;|
| Active Comparator: Control pasta<br>The participants consume pasta made from durum wheat semolina (fiber 2.7g/100g). | Other: Test meal<br>* The two test meals are designed to have the same energy and macronutrient composition. They differ only in the carbohydrate source: fiber-enriched pasta or control pasta. Blood samples are taken at fasting and every 30 minutes over 4 hours. Fasting and postprandial intestinal fermentation is evaluated by breath test.<br>* Other names: Acute test meal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose and lipid response | Evaluated by enzymatic colorimetric methods | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin response | Evaluated by ELISA | 4 hours | 
| Hormone response (GLP-1, GIP, PYY and Ghrelin) | Evaluated by ELISA | 4 hours | 
| Energy intake in the subsequent meal. | Evaluated by food record | 4 hours |