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Effect of Pasta on Blood Glucose Response in Normal Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 3, 2011
First Posted Date  ICMJE November 10, 2011
Last Update Posted Date November 11, 2011
Study Start Date  ICMJE April 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
Change in Blood Glucose [ Time Frame: 0, 30, 60, 90, 120, and 180 minutes after ingestion ]
Blood glucose will be determined by finger stick.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01469312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pasta on Blood Glucose Response in Normal Subjects
Official Title  ICMJE Effect of Pasta on Blood Glucose Response in Normal Subjects
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Condition  ICMJE
  • Blood Glucose Concentration
  • Type 2 Diabetes
  • Metabolic Syndrome
Intervention  ICMJE Other: modified pasta
50 grams carbohydrate as a single breakfast meal
Other Name: Dreamfields Pasta, Miracle Noodles
Study Arms  ICMJE
  • Placebo Comparator: Control
    The control arm consists of the traditional pasta.
    Intervention: Other: modified pasta
  • Active Comparator: Modified pasta
    Dreamfields, Miracle Noodles
    Intervention: Other: modified pasta
Publications * Nuttall FQ, Schweim K, Hoover H, Gannon MC. Effect of the LoBAG30 diet on blood glucose control in people with type 2 diabetes. Br J Nutr. 2008 Mar;99(3):511-9. Epub 2007 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal blood glucose concentration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01469312
Other Study ID Numbers  ICMJE 4231
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frank Q. Nuttall, MD, PhD, Minneapolis Veterans Affairs Medical Center
Study Sponsor  ICMJE Minneapolis Veterans Affairs Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Minneapolis Veterans Affairs Medical Center
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP