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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842606
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Test meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of the Consumption of Fiber-enriched Pasta on Glucose and Lipid Metabolism and Satiety
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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 Name: 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 Name: Acute test meal




Primary Outcome Measures :
  1. Glucose and lipid response [ Time Frame: 4 hours ]
    Evaluated by enzymatic colorimetric methods


Secondary Outcome Measures :
  1. Insulin response [ Time Frame: 4 hours ]
    Evaluated by ELISA

  2. Hormone response (GLP-1, GIP, PYY and Ghrelin) [ Time Frame: 4 hours ]
    Evaluated by ELISA

  3. Energy intake in the subsequent meal. [ Time Frame: 4 hours ]
    Evaluated by food record



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: rivellese angela, Full professor, Federico II University
ClinicalTrials.gov Identifier: NCT02842606    
Other Study ID Numbers: 166/14
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No