Diabetes Mellitus, Type 1NCT03362151
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)
A study testing Regular pasta, High protein pasta and White rice in people with Diabetes Mellitus, Type 1, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Regular pasta, High protein pasta and White rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 2 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Regular pasta, High protein pasta, White rice
- Keywords
- type 1 diabetes, pasta, rice, protein, carbohydrate
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular pastaOther
Regular pasta (Approximately 42 grams carbohydrate per meal)
High protein pastaOther
High protein pasta (Approximately 38 grams carbohydrate per meal)
White riceOther
White rice (Approximately 43 grams carbohydrate per meal)
| Study group | Role | What they receive |
|---|---|---|
| Regular pasta | Experimental | 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. Receives: Other: Regular pasta |
| High protein pasta | Experimental | 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. Receives: Other: High protein pasta |
| White rice | Experimental | 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. Receives: Other: White rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 hours
Secondary outcomes (3)
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.
Measured: 5 hours
Time to peak glucose level (minutes)
Time to peak glucose level (in minutes from intervention)
Measured: 5 hours
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.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jan 2018
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Sponsor
- Investigators
- David Eisenberg, MD, Principal investigator, Harvard School of Public Health (HSPH)Eyal Dassau, PhD, Principal investigator, Harvard UniversityJordan E Pinsker, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362151
- Sponsor's protocol ID
- IRB17-1316
- Status last verified
- Sep 2018
- First submitted
- 29 Nov 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31225739
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03362151
- Acronym / sponsor ID
- IRB17-1316
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1 diabetes, pasta, rice, protein, carbohydrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Regular pasta | Experimental | Other: Regular pastaSubjects 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. |
| High protein pasta | Experimental | Other: High protein pastaSubjects 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. |
| White rice | Experimental | Other: White riceSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular pastaRegular pasta (Approximately 42 grams carbohydrate per meal) | Other | Regular pasta |
| High protein pastaHigh protein pasta (Approximately 38 grams carbohydrate per meal) | Other | High protein pasta |
| White riceWhite rice (Approximately 43 grams carbohydrate per meal) | Other | White rice |
Primary outcome
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.
3 secondary outcomes
Incremental area under the curve (area)
Time frame: 5 hours
Time to peak glucose level (minutes)
Time frame: 5 hours
percent time glucose <70 mg/dL
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 31225739Zavitsanou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Eisenberg, MD principal investigator
Harvard School of Public Health (HSPH)
Eyal Dassau, PhD principal investigator
Harvard University
Jordan E Pinsker, MD principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular pasta, High protein pasta and White rice in people with Diabetes Mellitus, Type 1, run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta glucose (maximum rise from baseline glucose) mg/dL (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.