Metabolic Response to the Acute Consumption of Fiber-enriched Pasta

Healthy Volunteers Clinical Trial

— PROPASTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842606
• Other study ID #: 166/14
• Status: Completed
• Phase: N/A
• First received: July 15, 2016
• Last updated: August 9, 2017
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Test 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose and lipid response	Evaluated by enzymatic colorimetric methods	4 hours
Secondary	Insulin response	Evaluated by ELISA	4 hours
Secondary	Hormone response (GLP-1, GIP, PYY and Ghrelin)	Evaluated by ELISA	4 hours
Secondary	Energy intake in the subsequent meal.	Evaluated by food record	4 hours