Glycemic Index of Pasta From Traditional and Current Wheat Varieties

NCT ID: NCT05143827

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-20

Study Completion Date

2022-09-30

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.

Detailed Description

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Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Senatore Cappelli pasta

Group Type EXPERIMENTAL

Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)

Intervention Type OTHER

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

Korasan pasta

Group Type EXPERIMENTAL

Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)

Intervention Type OTHER

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

Claudio pasta

Group Type ACTIVE_COMPARATOR

Pasta manufactured with current wheat varieties (Claudio)

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role lead

Responsible Party

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Edoardo Mannucci

Director, Diabetology unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diabetologia AOU Careggi

Florence, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Edoardo Mannucci

Role: CONTACT

3387861041

Ilaria Dicembrini

Role: CONTACT

3333083735

Facility Contacts

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Ilaria Dicembrini, MD

Role: primary

0557946512

Other Identifiers

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15425-IGGA1

Identifier Type: -

Identifier Source: org_study_id

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