- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01469312
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:
|
Active Comparator: Modified pasta
Dreamfields, Miracle Noodles
|
50 grams carbohydrate as a single breakfast meal
Other Names:
|
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4231
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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