Effect of Pasta on Blood Glucose Response in Normal Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01469312
First received: November 3, 2011
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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 Intervention
Blood Glucose Concentration
Type 2 Diabetes
Metabolic Syndrome
Other: modified pasta

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Effect of Pasta on Blood Glucose Response in Normal Subjects

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Change in Blood Glucose [ Time Frame: 0, 30, 60, 90, 120, and 180 minutes after ingestion ] [ Designated as safety issue: No ]
    Blood glucose will be determined by finger stick.


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal blood glucose concentration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: November 3, 2011
Last Updated: November 9, 2011
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Low Biologically Available Glucose Diet (LoBAG diet)
Diabetes
Glycemic Index

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on July 22, 2014