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OpenTrials
Completed

NCT Number: NCT02842606

Metabolic Response to the Acute Consumption of Fiber-enriched Pasta

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.

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Key information

Conditions

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test meal

Other

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

Primary outcomes

  1. Glucose and lipid response

    Time frame: 4 hours

    Evaluated by enzymatic colorimetric methods

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: PROPASTA

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 25, 2016
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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