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Effect of Pasta on Blood Glucose Response in Normal Subjects

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ClinicalTrials.gov Identifier: NCT01469312
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : November 11, 2011
Sponsor:
Information provided by (Responsible Party):
Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Glucose Concentration Type 2 Diabetes Metabolic Syndrome Other: modified pasta Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Effect of Pasta on Blood Glucose Response in Normal Subjects
Study Start Date : April 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in Blood Glucose [ Time Frame: 0, 30, 60, 90, 120, and 180 minutes after ingestion ]
    Blood glucose will be determined by finger stick.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal blood glucose concentration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469312


Locations
United States, Minnesota
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Frank Q Nuttall, M.D., Ph.D. Minneapolis VA Health Care System
Principal Investigator: Mary C Gannon, Ph.D. Minneapolis VA Health Care System

Publications:
Responsible Party: Frank Q. Nuttall, MD, PhD, Chief, Section of Endocrinology, Metabolism & Nutrition, Professor of Medicine, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01469312     History of Changes
Other Study ID Numbers: 4231
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011

Keywords provided by Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center:
Low Biologically Available Glucose Diet (LoBAG diet)
Diabetes
Glycemic Index

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases