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CompletedNCT02842606PROPASTAUpdated Aug 10, 2017

Metabolic Response to the Acute Consumption of Fiber-enriched Pasta

An interventional study of Test meal in Healthy Volunteers, sponsored by Federico II University. Completed. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-10.

Sponsored by Federico II University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Healthy Volunteers
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In context

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI 18-29 kg / m2
  • Good Health status

Exclusion criteria

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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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Fiber-enriched pasta

    The participants consume whole wheat pasta with added fiber (fiber 12 g fiber/100 g).

    Other: Test meal

  • Active comparator
    Control pasta

    The participants consume pasta made from durum wheat semolina (fiber 2.7g/100g).

    Other: Test meal

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.

    Also known as: Acute test meal

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What researchers measure

Primary outcomes

  1. Glucose and lipid response

    Evaluated by enzymatic colorimetric methods

    Time frame: 4 hours

Secondary outcomes

  1. Insulin response

    Evaluated by ELISA

    Time frame: 4 hours

  2. Hormone response (GLP-1, GIP, PYY and Ghrelin)

    Evaluated by ELISA

    Time frame: 4 hours

  3. Energy intake in the subsequent meal.

    Evaluated by food record

    Time frame: 4 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02842606
Lead sponsor
Federico II University
Responsible party
rivellese angela (Full professor, Federico II University) — Principal investigator
First posted
Jul 25, 2016
Start date
Mar 2015
Primary completion
Jul 2015
Completion
Jul 2016
Last update
Aug 10, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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