A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03362151|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Other: Regular pasta Other: High protein pasta Other: White rice||Not Applicable|
The aim of this clinical study is to investigate and compare the postprandial glycemic response to three different meal types rich in carbohydrates, that is, white pasta, high protein pasta and white rice consumed by individuals with T1DM and to demonstrate that:
- The choice of carbohydrates consumed significantly affects the postprandial glycemic profile in people with type 1 diabetes and
- The consumption of high protein pasta will present a tighter postprandial glycemic response.
Previous studies have evaluated the effect of white pasta and rice on postprandial glycemic response in people with type 1 diabetes. With this study, we aim to expand upon these findings by ensuring that the results can still be applied to more recent commercial food products (pasta, rice), but especially to evaluate the effect of high-protein pasta when compared to regularly consumed carbohydrates (white pasta, white rice).
After consuming the study meal, subjects will participate in an education session (a 2 hour class per each meal challenge session). Classes will be taught by a registered dietician and diabetes & exercise expert and, as appropriate, a culinary instructor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
Subjects will consume pre-determined meals on 6 difference occasions. There will be three categories of "study meals" consisting of:
Each subject will consume each meal on two separate occasions in random order.
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Subjects will not be told which meal they are eating.|
|Official Title:||A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||August 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
Experimental: Regular pasta
Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of regular pasta. They will consume this meal on two separate occasions.
Other: Regular pasta
Regular pasta (Approximately 42 grams carbohydrate per meal)
Experimental: High protein pasta
Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of high protein pasta. They will consume this meal on two separate occasions.
Other: High protein pasta
High protein pasta (Approximately 38 grams carbohydrate per meal)
Experimental: White rice
Subjects will bolus rapid acting insulin per their carbohydrate ratio just prior to a meal of white rice. They will consume this meal on two separate occasions.
Other: White rice
White rice (Approximately 43 grams carbohydrate per meal)
- Delta glucose (maximum rise from baseline glucose) mg/dL [ Time Frame: 5 hours ]Delta glucose (maximum rise from baseline glucose) from the start of the meal to the peak continuous glucose monitoring (CGM) glucose reading (mg/dL) during the 5-hour postprandial window, compared between the three meal types.
- Incremental area under the curve (area) [ Time Frame: 5 hours ]Incremental area under the curve (iAUC) glucose level for the 5 hour postprandial period adjusted for baseline glucose at the start of the meal.
- Time to peak glucose level (minutes) [ Time Frame: 5 hours ]Time to peak glucose level (in minutes from intervention)
- percent time glucose <70 mg/dL [ Time Frame: 5 hours ]In case of postprandial hypoglycemia, percent time glucose <70 mg/dL for the 5 hour postprandial period will be evaluated.
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): NCT03362151
|Contact: Jennifer Massafirstname.lastname@example.org|
|United States, California|
|Sansum Diabetes Research Institute||Recruiting|
|Santa Barbara, California, United States, 93105|
|Contact: Camille Andre 805-682-7640 ext 217 email@example.com|
|Principal Investigator: Jordan E Pinsker, MD|
|Sub-Investigator: Mei Mei Church, NP|
|Principal Investigator:||David Eisenberg, MD||Harvard T.H. Chan School of Public Health|
|Principal Investigator:||Eyal Dassau, PhD||Harvard John A. Paulson School of Engineering and Applied Sciences|
|Principal Investigator:||Jordan E Pinsker, MD||Sansum Diabetes Research Institute|