NCT04494607

Brief Summary

he project aims to evaluate the glycemic index of different types of pasta with different formats and with different types of flour. In particular, we want to know the effect of the format and the different type of flour on the glycemic and insulinemic response. Specific objective 1: determination of the glycemic index of the product concerned. Specific objective 2: determination of the insulinemic index of the product concerned. Specific objective 3: determination of the pasta format and the type of flour with a lower glycemic and insulinemic index.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

June 15, 2020

Last Update Submit

July 28, 2020

Conditions

Glycemic Index

Outcome Measures

Primary Outcomes (1)

  • Glycemic Index determination

    determination of the glycemic index for the product in study

    1 year

Secondary Outcomes (1)

  • Insulinemic Index determination

    1 year

Other Outcomes (1)

  • Best cereal made product identification

    1,5 years

Study Arms (1)

Test arm

EXPERIMENTAL

Determination of Glycemic and Insulinemic curves under different alimentary intake

Dietary Supplement: lowest Glycemic Index for a selected type fo cereal product

Interventions

lowest Glycemic Index for a selected type fo cereal productDIETARY_SUPPLEMENT

determination of lowest Glycemic Index for a selected type fo cereal product

Test arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects
  • No carbohydrate intolerance or diabetes

You may not qualify if:

  • Intolerance ascertained to the products in study (celiac syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Maria Gabriella Dr Caruso, MD

CONTACT

+390804994651gabriella.caruso@irccsdebellis.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

June 15, 2020

First Posted

July 31, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

July 31, 2020

Record last verified: 2020-07