Glycemic Index of Pasta From Traditional and Current Wheat Varieties

Study Overview
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Brief Summary
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This randomized, cross-over study compares pasta produced with three different wheat varieties (Senatore Cappelli, Korasan, Claudio). Patients with type 2 diabetes with no pharmacological treatment will be randomized to three different sequences, and asked to eat a standard portion of pasta on three different occasions, four days apart. 3-hour post-prandial interstitial glucose profiles will be recorded using trans-cutaneous sensors.

Official Title
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Glycemic Index of Pasta From Traditional and Current Wheat Varieties in Patients With Type 2 Diabetes: a Randomized, Cross-over, Blind Study

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Other: Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)
* Other: Pasta manufactured with current wheat varieties (Claudio)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Body Mass Index (BMI) > 20 kg/m2 HbA1c < 58 mmol/mol Exclusion Criteria: Current pharmacological therapy for diabetes (of any kind) Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Senatore Cappelli pasta<br> | Other: Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)<br>* A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties<br>|
| Experimental: Korasan pasta<br> | Other: Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)<br>* A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties<br>|
| Active Comparator: Claudio pasta<br> | Other: Pasta manufactured with current wheat varieties (Claudio)<br>* A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60-min glucose | Glucose (interstitial monitoring) 60 min after beginning of meal | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-min glucose | Glucose (interstitial monitoring) 30 min after beginning of meal | 30 minutes | 
| 90-min glucose | Glucose (interstitial monitoring) 90 min after beginning of meal | 90 minutes | 
| 120-min glucose | Glucose (interstitial monitoring) 120 min after beginning of meal | 120 minutes | 
| 150-min glucose | Glucose (interstitial monitoring) 150 min after beginning of meal | 150 minutes | 
| 180-min glucose | Glucose (interstitial monitoring) 180 min after beginning of meal | 180 minutes | 
| Area Under the Curve (AUC) glucose 30 min | Area under glucose (interstitial monitoring) curve 30 min after beginning of meal | 30 minutes | 
| AUC glucose 60 min | Area under glucose (interstitial monitoring) curve 60 min after beginning of meal | 60 minutes | 
| AUC glucose 90 min | Area under glucose (interstitial monitoring) curve 90 min after beginning of meal | 90 minutes | 
| AUC glucose 120 min | Area under glucose (interstitial monitoring) curve 120 min after beginning of meal | 120 minutes | 
| AUC glucose 180 min | Area under glucose (interstitial monitoring) curve 180 min after beginning of meal | 180 minutes |