Glycemic Index of Pasta From Traditional and Current Wheat Varieties

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Type 2
• Intervention / Treatment: Other: Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan); Other: Pasta manufactured with current wheat varieties (Claudio)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edoardo Mannucci; Phone Number: 3387861041; Email: edoardo.mannucci@unifi.it
• Study Contact Backup: Name: Ilaria Dicembrini; Phone Number: 3333083735; Email: ilaria.dicembrini@unifi.it

Study Locations

• Italy
  • Firenze, Italy, 50134
    • Recruiting
    • Diabetologia AOU Careggi
    • Contact: Ilaria Dicembrini, MD; Phone Number: 0557946512; Email: idicembrini@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 15425-IGGA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No