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Glycemic Index of Pasta From Traditional and Current Wheat Varieties

A

Azienda Ospedaliero-Universitaria Careggi

Status

Enrolling

Conditions

Diabetes Type 2

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05143827
15425-IGGA1

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 3 patient groups

Senatore Cappelli pasta
Experimental group
Treatment:
Other: Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)
Korasan pasta
Experimental group
Treatment:
Other: Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)
Claudio pasta
Active Comparator group
Treatment:
Other: Pasta manufactured with current wheat varieties (Claudio)

Trial contacts and locations

1

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Central trial contact

Ilaria Dicembrini; Edoardo Mannucci

Data sourced from clinicaltrials.gov

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