Glycemic IndexNCT05333081
Glycemic Index of Italian Rice Varieties
A study testing Consumption of rice for evaluation of the glycemic index in people with Glycemic Index, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- Consumption of rice for evaluation of the glycemic index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jun 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no known foood allergy or intolerance
- no medications to affect glucose tolerance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda di Servizi alla Persona
Pavia, 27100
Mariangela Rondanelli, mariangela.rondanelli@unipv.it
About this study
Official title: Determination of the Glycemic Index of 25 Italian Rice Varieties
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.
- Conditions
- Glycemic Index
- Being tested
- Consumption of rice for evaluation of the glycemic index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of rice for evaluation of the glycemic indexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of the glycemic index | Other | Not described Receives: Other: Consumption of rice for evaluation of the glycemic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of glucose response
Gycemia (mg/dl)
Measured: From baseline to 120 min after rice consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start8 Jun 2021
- Primary completion20 Jun 2021
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycemic IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333081
- Sponsor's protocol ID
- 0107/11012022
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37262189
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Glycemic Index of 25 Italian Rice Varieties
- ClinicalTrials.gov ID
- NCT05333081
- Acronym / sponsor ID
- 0107/11012022
- Conditions
- Glycemic Index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the glycemic index | Other | Other: Consumption of rice for evaluation of the glycemic index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- no known foood allergy or intolerance
- no medications to affect glucose tolerance
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumption of rice for evaluation of the glycemic indexThe 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. | Other | Evaluation of the glycemic index |
Primary outcome
Evaluation of glucose response
Time frame: From baseline to 120 min after rice consumption
Gycemia (mg/dl)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Derived from this study: PubMed 37262189Rondanelli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of rice for evaluation of the glycemic index in people with Glycemic Index, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariangela Rondanelli (+390382381749, mariangela.rondanelli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of glucose response (time frame: From baseline to 120 min after rice consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05333081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.