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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)

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Regular pasta

High protein pasta

White rice

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring type 1 diabetes, pasta, rice, protein, carbohydrate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 and ≤ 75 years at the time of screening.
Clinical diagnosis of type 1 diabetes for at least one year.
HbA1c ≤ 10%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes, and boluses for all meals and snacks that contain ≥ 5 grams of carbohydrate.
Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile at the screening visit. Subjects who become pregnant will be discontinued from the study.
Willing to abide by the study protocol and use study-provided devices.

Exclusion Criteria:

Gastrointestinal disease such as celiac disease or multiple food allergies.
Any form of gluten sensitivity or wheat allergy.
Allergies to any form of nuts and ingredients present in the study meals (tomatoes etc).
History of gastroparesis.
Pregnancy.
Dermatological conditions that would preclude wearing a CGM sensor.
Screening A1c > 10%.
Any condition that could interfere with participating in the trial, based on the investigator's judgment.
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

Sites / Locations

Sansum Diabetes Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Regular pasta

High protein pasta

White rice

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Delta glucose (maximum rise from baseline glucose) mg/dL

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.

Secondary Outcome Measures

Incremental area under the curve (area)

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 to peak glucose level (in minutes from intervention)

percent time glucose <70 mg/dL

In case of postprandial hypoglycemia, percent time glucose <70 mg/dL for the 5 hour postprandial period will be evaluated.

Full Information

NCT ID

NCT03362151

First Posted

November 29, 2017

Last Updated

September 4, 2018

Sponsor

Sansum Diabetes Research Institute

Collaborators

Harvard University

1. Study Identification

Unique Protocol Identification Number

NCT03362151

Brief 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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

August 2, 2018 (Actual)

Study Completion Date

August 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sansum Diabetes Research Institute

Collaborators

Harvard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes, pasta, rice, protein, carbohydrate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Subjects will consume pre-determined meals on 6 difference occasions. There will be three categories of "study meals" consisting of: Regular pasta (42 grams carbohydrate per meal) High protein pasta (38 grams carbohydrate per meal) White rice (43 grams carbohydrate per meal) Each subject will consume each meal on two separate occasions in random order.

Masking

ParticipantInvestigator

Masking Description

Subjects will not be told which meal they are eating.

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regular pasta

Arm Type

Experimental

Arm Description

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.

Arm Title

High protein pasta

Arm Type

Experimental

Arm Description

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.

Arm Title

White rice

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Regular pasta

Intervention Description

Regular pasta (Approximately 42 grams carbohydrate per meal)

Intervention Type

Other

Intervention Name(s)

High protein pasta

Intervention Description

High protein pasta (Approximately 38 grams carbohydrate per meal)

Intervention Type

Other

Intervention Name(s)

White rice

Intervention Description

White rice (Approximately 43 grams carbohydrate per meal)

Primary Outcome Measure Information:

Title

Delta glucose (maximum rise from baseline glucose) mg/dL

Description

Time Frame

5 hours

Secondary Outcome Measure Information:

Title

Incremental area under the curve (area)

Description

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 Frame

5 hours

Title

Time to peak glucose level (minutes)

Description

Time to peak glucose level (in minutes from intervention)

Time Frame

5 hours

Title

percent time glucose <70 mg/dL

Description

In case of postprandial hypoglycemia, percent time glucose <70 mg/dL for the 5 hour postprandial period will be evaluated.

Time Frame

5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 and ≤ 75 years at the time of screening. Clinical diagnosis of type 1 diabetes for at least one year. HbA1c ≤ 10%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment. Currently using insulin-to-carbohydrate ratio to calculate meal bolus sizes, and boluses for all meals and snacks that contain ≥ 5 grams of carbohydrate. Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours. For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile at the screening visit. Subjects who become pregnant will be discontinued from the study. Willing to abide by the study protocol and use study-provided devices. Exclusion Criteria: Gastrointestinal disease such as celiac disease or multiple food allergies. Any form of gluten sensitivity or wheat allergy. Allergies to any form of nuts and ingredients present in the study meals (tomatoes etc). History of gastroparesis. Pregnancy. Dermatological conditions that would preclude wearing a CGM sensor. Screening A1c > 10%. Any condition that could interfere with participating in the trial, based on the investigator's judgment. A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol. Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Eisenberg, MD

Organizational Affiliation

Harvard School of Public Health (HSPH)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eyal Dassau, PhD

Organizational Affiliation

Harvard University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jordan E Pinsker, MD

Organizational Affiliation

Sansum Diabetes Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sansum Diabetes Research Institute

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31225739

Citation

Zavitsanou S, Massa J, Deshpande S, Pinsker JE, Church MM, Andre C, Doyle Iii FJ, Michelson A, Creason J, Dassau E, Eisenberg DM. The Effect of Two Types of Pasta Versus White Rice on Postprandial Blood Glucose Levels in Adults with Type 1 Diabetes: A Randomized Crossover Trial. Diabetes Technol Ther. 2019 Sep;21(9):485-492. doi: 10.1089/dia.2019.0109. Epub 2019 Jun 21.

Results Reference

derived

Learn more about this trial

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)

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