NCT02842606

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable healthy-volunteers

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
Last Updated

August 10, 2017

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

July 15, 2016

Last Update Submit

August 9, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Glucose and lipid response

    Evaluated by enzymatic colorimetric methods

    4 hours

Secondary Outcomes (3)

  • Insulin response

    4 hours

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

    4 hours

  • Energy intake in the subsequent meal.

    4 hours

Study Arms (2)

Fiber-enriched pasta

EXPERIMENTAL

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

Other: Test meal

Control pasta

ACTIVE COMPARATOR

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

Other: Test meal

Interventions

Test mealOTHER

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
Control pastaFiber-enriched pasta

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes
  • Cardiovascular events (IMA or stroke) severe heart disease
  • Kidney or liver failure
  • Anemia and any other chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 25, 2016

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

August 10, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share