Clinical trial NCT03362151: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes
pasta
rice
protein
carbohydrate
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2017-12-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will consume pre-determined meals on 6 difference occasions. There will be three categories of "study meals" consisting of:

1. Regular pasta (42 grams carbohydrate per meal)
2. High protein pasta (38 grams carbohydrate per meal)
3. White rice (43 grams carbohydrate per meal)

Each subject will consume each meal on two separate occasions in random order.
Primary purpose: TREATMENT

Brief summary: 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.

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:

1. The choice of carbohydrates consumed significantly affects the postprandial glycemic profile in people with type 1 diabetes and
2. 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.

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.

Primary outcomes:
measure: Delta glucose (maximum rise from baseline glucose) mg/dL
timeFrame: 5 hours
Secondary outcomes:
measure: Incremental area under the curve (area)
timeFrame: 5 hours
measure: Time to peak glucose level (minutes)
timeFrame: 5 hours
measure: percent time glucose <70 mg/dL
timeFrame: 5 hours
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: David Eisenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Eyal Dassau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sansum Diabetes Research Institute
name: Jordan E Pinsker, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.