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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05333081
Other study ID # 0107/11012022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 8, 2021
Est. completion date May 31, 2022

Study information

Verified date April 2022
Source Azienda di Servizi alla Persona di Pavia
Contact Mariangela Rondanelli
Phone +390382381749
Email mariangela.rondanelli@unipv.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date May 31, 2022
Est. primary completion date June 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - no known foood allergy or intolerance - no medications to affect glucose tolerance Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Azienda di Servizi alla Persona Pavia

Sponsors (1)

Lead Sponsor Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of glucose response Gycemia (mg/dl) From baseline to 120 min after rice consumption
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