Metabolic Response to the Acute Consumption of Fiber-enriched Pasta (PROPASTA)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Test meal

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fiber-enriched pasta; The participants consume whole wheat pasta with added fiber (fiber 12 g fiber/100 g).	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.; Other Names: Acute test meal
Active Comparator: Control pasta; The participants consume pasta made from durum wheat semolina (fiber 2.7g/100g).	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.; Other Names: Acute test meal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 166/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No