Healthy Volunteers
Conditions
Brief summary
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.
Interventions
OTHERTest meal
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.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose and lipid response | 4 hours | Evaluated by enzymatic colorimetric methods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin response | 4 hours | Evaluated by ELISA |
| Hormone response (GLP-1, GIP, PYY and Ghrelin) | 4 hours | Evaluated by ELISA |
| Energy intake in the subsequent meal. | 4 hours | Evaluated by food record |
Outcome results
None listed