Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease

December 20, 2017 updated by: rivellese angela, Federico II University

Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial

The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Department of Clinical Medicine and Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 20-50 years
  • Documented history of celiac disease and type 1 diabetes.

Exclusion Criteria:

  • Pregnancy/breast feeding
  • Serious microvascular and macrovascular diabetes complications
  • Any other chronic or acute disease apart from diabetes seriously affecting health status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fiber-enriched buckwheat pasta
Acute test meal
Other: Acute test meal with fiber-enriched buckwheat pasta
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
Active Comparator: Corn pasta
Acute test meal
Other: Acute test meal with corn pasta
Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucose response
Time Frame: 6 hours
Incremental area under the curve
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 175/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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