NCT05333081

Brief Summary

The service commissioned by the National Rice Authority required the evaluation of the Glycemic Index of 25 varieties of rice. As a reference, both for the comparison and for the calculation of the Glycemic Index, glucose was used, which clearly has characteristics of greater uniformity than white bread and was preferred because it is better suited to be used as a standard of measurement. In accordance with the ISO 26642 standard, a panel of selected volunteers (consisting of 10 subjects), healthy, not suffering from diabetes or other pathologies of glucose metabolism, were included in the study. As per protocol, the changes in glycaemia of all the subjects involved were evaluated after the intake of glucose (50g), as a standard food, and of rice (50g of available carbohydrates), taking into account the carbohydrate content of each variety. to determine the amount of rice to be fed. The test of each food was carried out for a maximum time of 120 minutes, by carrying out repeated measurements of the glycaemia of all subjects at a distance of 0, 15, 30, 45, 60, 90 and 120 minutes from the administration of the sample in order to obtain a glycemic curve for each sample considered. From the analysis of the area underlying the glycemic curve of each variety, it was possible to determine the Glycemic Index.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

12 days

First QC Date

April 11, 2022

Last Update Submit

April 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of glucose response

    Gycemia (mg/dl)

    From baseline to 120 min after rice consumption

Study Arms (1)

Evaluation of the glycemic index

OTHER
Other: Consumption of rice for evaluation of the glycemic index

Interventions

The test of each food was carried out for a maximum time of 120 minutes, by carrying out repeated measurements of the glycaemia of all subjects at a distance of 0, 15, 30, 45, 60, 90 and 120 minutes from the administration of the sample in order to obtain a glycemic curve for each sample considered.

Evaluation of the glycemic index

Eligibility Criteria

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

You may qualify if:

  • no known foood allergy or intolerance
  • no medications to affect glucose tolerance

You may not qualify if:

  • Diabetes mellitus or insulin disorders
  • major event or surgical procedure requiring hospitalization within the preceding 3 months
  • disease or drugs that influcence digestion and absorbtion of nutrients
  • the use of steroids, protease inhibitors or antipsychotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda di Servizi alla Persona

Pavia, 27100, Italy

RECRUITING

Related Publications (1)

  • Rondanelli M, Ferrario RA, Barrile GC, Guido D, Gasparri C, Ferraris C, Cavioni A, Mansueto F, Mazzola G, Patelli Z, Peroni G, Pirola M, Razza C, Tartara A, Perna S. The Glycemic Index of Indica and Japonica Subspecies Parboiled Rice Grown in Italy and the Effect on Glycemic Index of Different Parboiling Processes. J Med Food. 2023 Jun;26(6):422-427. doi: 10.1089/jmf.2022.0120. Epub 2023 Jun 1.

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 18, 2022

Study Start

June 8, 2021

Primary Completion

June 20, 2021

Study Completion

May 31, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations