CClinicalTrials.gg
Status unknownNCT05143827Updated Jul 20, 2022

Glycemic Index of Pasta From Traditional and Current Wheat Varieties

An interventional study of Pasta manufactured with traditional wheat varieties (Senatore Cappelli, Korasan) and Pasta manufactured with current wheat varieties (Claudio) in Diabetes Type 2, sponsored by Azienda Ospedaliero-Universitaria Careggi. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 75 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • Body Mass Index (BMI) > 20 kg/m2
  • HbA1c \< 58 mmol/mol

Exclusion criteria

Exclusion Criteria:

  • Current pharmacological therapy for diabetes (of any kind)
  • Pregnancy or lactation
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Senatore Cappelli pasta

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

  • Experimental
    Korasan pasta

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

  • Active comparator
    Claudio pasta

    Other: Pasta manufactured with current wheat varieties (Claudio)

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

06

What researchers measure

Primary outcomes

  1. 60-min glucose

    Glucose (interstitial monitoring) 60 min after beginning of meal

    Time frame: 60 minutes

Secondary outcomes

  1. 30-min glucose

    Glucose (interstitial monitoring) 30 min after beginning of meal

    Time frame: 30 minutes

  2. 90-min glucose

    Glucose (interstitial monitoring) 90 min after beginning of meal

    Time frame: 90 minutes

  3. 120-min glucose

    Glucose (interstitial monitoring) 120 min after beginning of meal

    Time frame: 120 minutes

  4. 150-min glucose

    Glucose (interstitial monitoring) 150 min after beginning of meal

    Time frame: 150 minutes

  5. 180-min glucose

    Glucose (interstitial monitoring) 180 min after beginning of meal

    Time frame: 180 minutes

  6. Area Under the Curve (AUC) glucose 30 min

    Area under glucose (interstitial monitoring) curve 30 min after beginning of meal

    Time frame: 30 minutes

  7. AUC glucose 60 min

    Area under glucose (interstitial monitoring) curve 60 min after beginning of meal

    Time frame: 60 minutes

  8. AUC glucose 90 min

    Area under glucose (interstitial monitoring) curve 90 min after beginning of meal

    Time frame: 90 minutes

  9. AUC glucose 120 min

    Area under glucose (interstitial monitoring) curve 120 min after beginning of meal

    Time frame: 120 minutes

  10. AUC glucose 180 min

    Area under glucose (interstitial monitoring) curve 180 min after beginning of meal

    Time frame: 180 minutes

07

Study locations

1 of 1 sites recruiting
  • Diabetologia AOU Careggi
    Firenze, 50134, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05143827
Lead sponsor
Azienda Ospedaliero-Universitaria Careggi
Responsible party
Edoardo Mannucci (Director, Diabetology unit, Azienda Ospedaliero-Universitaria Careggi) — Principal investigator
First posted
Dec 3, 2021
Start date
Nov 20, 2021
Primary completion
Aug 31, 2022 (estimated)
Completion
Sep 30, 2022 (estimated)
Last update
Jul 20, 2022

Study contacts

Edoardo Mannucci
Contact
edoardo.mannucci@unifi.it
3387861041
Ilaria Dicembrini
Contact
ilaria.dicembrini@unifi.it
3333083735

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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