Effect of Pasta on Blood Glucose Response in Normal Subjects
This study has been completed.
Sponsor:
Minneapolis Veterans Affairs Medical Center
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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 3, 2011 | ||||||||
| Last Updated Date | November 9, 2011 | ||||||||
| Start Date ICMJE | April 2010 | ||||||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
||||||||
| 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 Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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 | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Other: modified pasta
50 grams carbohydrate as a single breakfast meal
Other Name: Dreamfields Pasta, Miracle Noodles |
||||||||
| Study Arm (s) |
|
||||||||
| 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 | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | October 2011 | ||||||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01469312 | ||||||||
| Other Study ID Numbers ICMJE | 4231 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| 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 |
|
||||||||
| Information Provided By | 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 |
|||||||||