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Glycemic Index of Pasta From Traditional and Current Wheat Varieties

Primary Purpose

Diabetes Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)
Pasta manufactured with current wheat varieties (Claudio)
Sponsored by
Azienda Ospedaliero-Universitaria Careggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diabetologia AOU CareggiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Senatore Cappelli pasta

Korasan pasta

Claudio pasta

Arm Description

Outcomes

Primary Outcome Measures

60-min glucose
Glucose (interstitial monitoring) 60 min after beginning of meal

Secondary Outcome Measures

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

Full Information

First Posted
November 23, 2021
Last Updated
July 19, 2022
Sponsor
Azienda Ospedaliero-Universitaria Careggi
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1. Study Identification

Unique Protocol Identification Number
NCT05143827
Brief Title
Glycemic Index of Pasta From Traditional and Current Wheat Varieties
Official Title
Glycemic Index of Pasta From Traditional and Current Wheat Varieties in Patients With Type 2 Diabetes: a Randomized, Cross-over, Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Careggi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Senatore Cappelli pasta
Arm Type
Experimental
Arm Title
Korasan pasta
Arm Type
Experimental
Arm Title
Claudio pasta
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan)
Intervention Description
A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties
Intervention Type
Other
Intervention Name(s)
Pasta manufactured with current wheat varieties (Claudio)
Intervention Description
A single meal composed of a portion of pasta (with standardized dressing) manufactured with different wheat varieties
Primary Outcome Measure Information:
Title
60-min glucose
Description
Glucose (interstitial monitoring) 60 min after beginning of meal
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
30-min glucose
Description
Glucose (interstitial monitoring) 30 min after beginning of meal
Time Frame
30 minutes
Title
90-min glucose
Description
Glucose (interstitial monitoring) 90 min after beginning of meal
Time Frame
90 minutes
Title
120-min glucose
Description
Glucose (interstitial monitoring) 120 min after beginning of meal
Time Frame
120 minutes
Title
150-min glucose
Description
Glucose (interstitial monitoring) 150 min after beginning of meal
Time Frame
150 minutes
Title
180-min glucose
Description
Glucose (interstitial monitoring) 180 min after beginning of meal
Time Frame
180 minutes
Title
Area Under the Curve (AUC) glucose 30 min
Description
Area under glucose (interstitial monitoring) curve 30 min after beginning of meal
Time Frame
30 minutes
Title
AUC glucose 60 min
Description
Area under glucose (interstitial monitoring) curve 60 min after beginning of meal
Time Frame
60 minutes
Title
AUC glucose 90 min
Description
Area under glucose (interstitial monitoring) curve 90 min after beginning of meal
Time Frame
90 minutes
Title
AUC glucose 120 min
Description
Area under glucose (interstitial monitoring) curve 120 min after beginning of meal
Time Frame
120 minutes
Title
AUC glucose 180 min
Description
Area under glucose (interstitial monitoring) curve 180 min after beginning of meal
Time Frame
180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edoardo Mannucci
Phone
3387861041
Email
edoardo.mannucci@unifi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Dicembrini
Phone
3333083735
Email
ilaria.dicembrini@unifi.it
Facility Information:
Facility Name
Diabetologia AOU Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Dicembrini, MD
Phone
0557946512
Email
idicembrini@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Glycemic Index of Pasta From Traditional and Current Wheat Varieties

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