Effect of Pasta on Blood Glucose Response in Normal Subjects

November 9, 2011 updated by: Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
The objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

On one occasion the pasta will be a traditionally available pasta; on another occasion, approximately 1 week later a modified pasta, advertised to contain ~ 5 grams of digestible carbohydrate, or to be low in digestible starch, will be studied.

Study Type

Interventional

Enrollment (Actual)

20

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

    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal blood glucose concentration

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
The control arm consists of the traditional pasta.
50 grams carbohydrate as a single breakfast meal
Other Names:
  • Dreamfields Pasta, Miracle Noodles
Active Comparator: Modified pasta
Dreamfields, Miracle Noodles
50 grams carbohydrate as a single breakfast meal
Other Names:
  • Dreamfields Pasta, Miracle Noodles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood Glucose
Time Frame: 0, 30, 60, 90, 120, and 180 minutes after ingestion
Blood glucose will be determined by finger stick.
0, 30, 60, 90, 120, and 180 minutes after ingestion

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Frank Q Nuttall, M.D., Ph.D., Minneapolis Veterans Affairs Medical Center
  • Principal Investigator: Mary C Gannon, Ph.D., Minneapolis Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

April 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 3, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Estimate)

November 11, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

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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