Glycemic Index of Pasta From Traditional and Current Wheat Varieties

Not Applicable

• Conditions: Diabetes Type 2
• Interventions: Other: Pasta manufactured with current wheat varieties (Claudio); Other: Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)

• Registration Number: NCT05143827
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-20
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Claudio pasta	Pasta manufactured with current wheat varieties (Claudio)	-
Korasan pasta	Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)	-
Senatore Cappelli pasta	Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)	-

Primary Outcome Measures

Name	Time	Method
60-min glucose	60 minutes	Glucose (interstitial monitoring) 60 min after beginning of meal

Secondary Outcome Measures

Name	Time	Method
30-min glucose	30 minutes	Glucose (interstitial monitoring) 30 min after beginning of meal
90-min glucose	90 minutes	Glucose (interstitial monitoring) 90 min after beginning of meal
AUC glucose 180 min	180 minutes	Area under glucose (interstitial monitoring) curve 180 min after beginning of meal
120-min glucose	120 minutes	Glucose (interstitial monitoring) 120 min after beginning of meal
Area Under the Curve (AUC) glucose 30 min	30 minutes	Area under glucose (interstitial monitoring) curve 30 min after beginning of meal
AUC glucose 60 min	60 minutes	Area under glucose (interstitial monitoring) curve 60 min after beginning of meal
AUC glucose 90 min	90 minutes	Area under glucose (interstitial monitoring) curve 90 min after beginning of meal
AUC glucose 120 min	120 minutes	Area under glucose (interstitial monitoring) curve 120 min after beginning of meal
150-min glucose	150 minutes	Glucose (interstitial monitoring) 150 min after beginning of meal
180-min glucose	180 minutes	Glucose (interstitial monitoring) 180 min after beginning of meal

Trial Locations

Locations (1)

Diabetologia AOU Careggi; 🇮🇹 Firenze, Italy