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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05143827
Enrollment
30
Registered
2021-12-03
Start date
2021-11-20
Completion date
2022-09-30
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

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.

Interventions

OTHERPasta 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

OTHERPasta manufactured with current wheat varieties (Claudio)

A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
60-min glucose60 minutesGlucose (interstitial monitoring) 60 min after beginning of meal

Secondary

MeasureTime frameDescription
90-min glucose90 minutesGlucose (interstitial monitoring) 90 min after beginning of meal
120-min glucose120 minutesGlucose (interstitial monitoring) 120 min after beginning of meal
150-min glucose150 minutesGlucose (interstitial monitoring) 150 min after beginning of meal
180-min glucose180 minutesGlucose (interstitial monitoring) 180 min after beginning of meal
30-min glucose30 minutesGlucose (interstitial monitoring) 30 min after beginning of meal
AUC glucose 60 min60 minutesArea under glucose (interstitial monitoring) curve 60 min after beginning of meal
AUC glucose 90 min90 minutesArea under glucose (interstitial monitoring) curve 90 min after beginning of meal
AUC glucose 120 min120 minutesArea under glucose (interstitial monitoring) curve 120 min after beginning of meal
AUC glucose 180 min180 minutesArea under glucose (interstitial monitoring) curve 180 min after beginning of meal
Area Under the Curve (AUC) glucose 30 min30 minutesArea under glucose (interstitial monitoring) curve 30 min after beginning of meal

Countries

Italy

Contacts

Primary ContactEdoardo Mannucci
edoardo.mannucci@unifi.it3387861041
Backup ContactIlaria Dicembrini
ilaria.dicembrini@unifi.it3333083735

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026