Glycemic IndexNCT04494607
Glycemic Index of Various Types of Pasta in Healthy Volunteers
A study testing lowest Glycemic Index for a selected type fo cereal product in people with Glycemic Index, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Index
- What is being tested?
- lowest Glycemic Index for a selected type fo cereal product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Dec 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- No carbohydrate intolerance or diabetes
Who cannot join
- Intolerance ascertained to the products in study (celiac syndrome)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Glycemic Index of Various Types of Pasta in Healthy Volunteers
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.
Read the detailed description
The study is divided into the following phases:
Phase 1: screening of subjects aimed at identifying possession of the inclusion criteria necessary for participation in the study;
Phase 2: Enrollment of the subject and for each of the enlisted subjects, execution of the first and second determination of the glycemic and insulinemic response curve with the standard glucose solution 30 days apart; 15 days after the second determination of the glycemic and insulinemic response to the glucose load, the assumption of the food test will be performed on which to measure the glycemic index (type of pasta) and evaluation of the glycemic and insulinemic response curve to this food ; finally, after a further 30 days, the third determination of the glycemic and insulinemic response curve will be performed with the standard glucose solution;
Phase 3: statistical processing of the results of phase 2 and determination of the glycemic index and insulinemic index for each type of pasta tested;
Phase 4: description of the results of phase 3 with indication to the supplier company of the pasta format and the type of flour with lower glycemic and insulinemic index.
More phases detailed:
Phase 1 Voluntarily enrolled subjects undergo a clinical history to exclude the pathologies present in the exclusion criteria and a routine blood sample to exclude metabolic alterations affecting the metabolism of sugars, lipids, uric acid, and liver.
Phase 2: The subjects considered suitable to enter the study will be subjected to the administration of the standard glucose solution for the determination of the first glycemic and insulinemic curve. The standard solution consists of 50 g of glucose dissolved in 200 cc of trace mineral water, which the subject will be invited to drink in about 10 minutes. Venous blood samples for the determination of glucose and insulin will be collected at time 0, and then at 15, 30, 45, 60, 90 and 120 minutes from the start of the standard intake of the glucose solution. In case of a normal response to the first determination of the glycemic and insulinemic curve, the subject will continue in the study; otherwise it will be excluded and will be directed to clinical study paths to assess the presence of any pathologies not yet concluded (diabetes, reduced response to insulin, etc.).
Follow all subjects eligible to continue the study and at least 12 participants, 30 days after the first glucose load curve, will be subjected to the second administration of the standard glucose solution according to the procedures described above.
After 15 days, the same subjects will be given a portion of pasta (food on which to measure the glycemic index) containing 50 grams of available carbohydrates. The determination of the quantity of carbohydrates inside the product (pasta) on which it determines the glycemic index must be done with a direct method and supplied by the food company together with the pasta samples. The subject will be invited to consume the pasta in 15 minutes while sipping 200 cc of mineral water at the same time. Blood samples for the determination of blood sugar and insulin will be collected at time 0, and then at 15, 30, 45, 60, 90 and 120 minutes from the start of the pasta intake.
After another 30 days, the third glucose response curve and all insulin will be performed on each subject, with the other modalities of the first two loading curves (this provides an average value of the subject's response to glucose over time).
Phase 3: Statistical processing of the results of phase 2 and determination of the glycemic index and insulinemic index for each type of pasta tested.
Phase 4: For each type of pasta tested, a detailed report will be drawn up, complete with graphs relating to the glycemic and insulinemic response for each subject. Each report will include the glycemic and insulinemic index values of the product concerned.
This will allow to determine which pasta format and which type of flour has the lowest glycemic and insulinemic index.
- Conditions
- Glycemic Index
- Being tested
- lowest Glycemic Index for a selected type fo cereal product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lowest Glycemic Index for a selected type fo cereal productDietary supplement
determination of lowest Glycemic Index for a selected type fo cereal product
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | Determination of Glycemic and Insulinemic curves under different alimentary intake Receives: Dietary Supplement: lowest Glycemic Index for a selected type fo cereal product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Index determination
determination of the glycemic index for the product in study
Measured: 1 year
Secondary outcomes (1)
Insulinemic Index determination
determination of the glycemic index for the product in study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Gabriella Caruso, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494607
- Sponsor's protocol ID
- RC2020_IRCCS
- Status last verified
- Jul 2020
- First submitted
- 15 Jun 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Glycemic Index of Various Types of Pasta in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04494607
- Acronym / sponsor ID
- RC2020_IRCCS
- Conditions
- Glycemic Index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Jul 2020 (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.
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.
Detailed description
The study is divided into the following phases:
Phase 1: screening of subjects aimed at identifying possession of the inclusion criteria necessary for participation in the study;
Phase 2: Enrollment of the subject and for each of the enlisted subjects, execution of the first and second determination of the glycemic and insulinemic response curve with the standard glucose solution 30 days apart; 15 days after the second determination of the glycemic and insulinemic response to the glucose load, the assumption of the food test will be performed on which to measure the glycemic index (type of pasta) and evaluation of the glycemic and insulinemic response curve to this food ; finally, after a further 30 days, the third determination of the glycemic and insulinemic response curve will be performed with the standard glucose solution;
Phase 3: statistical processing of the results of phase 2 and determination of the glycemic index and insulinemic index for each type of pasta tested;
Phase 4: description of the results of phase 3 with indication to the supplier company of the pasta format and the type of flour with lower glycemic and insulinemic index.
More phases detailed:
Phase 1 Voluntarily enrolled subjects undergo a clinical history to exclude the pathologies present in the exclusion criteria and a routine blood sample to exclude metabolic alterations affecting the metabolism of sugars, lipids, uric acid, and liver.
Phase 2: The subjects considered suitable to enter the study will be subjected to the administration of the standard glucose solution for the determination of the first glycemic and insulinemic curve. The standard solution consists of 50 g of glucose dissolved in 200 cc of trace mineral water, which the subject will be invited to drink in about 10 minutes. Venous blood samples for the determination of glucose and insulin will be collected at time 0, and then at 15, 30, 45, 60, 90 and 120 minutes from the start of the standard intake of the glucose solution. In case of a normal response to the first determination of the glycemic and insulinemic curve, the subject will continue in the study; otherwise it will be excluded and will be directed to clinical study paths to assess the presence of any pathologies not yet concluded (diabetes, reduced response to insulin, etc.).
Follow all subjects eligible to continue the study and at least 12 participants, 30 days after the first glucose load curve, will be subjected to the second administration of the standard glucose solution according to the procedures described above.
After 15 days, the same subjects will be given a portion of pasta (food on which to measure the glycemic index) containing 50 grams of available carbohydrates. The determination of the quantity of carbohydrates inside the product (pasta) on which it determines the glycemic index must be done with a direct method and supplied by the food company together with the pasta samples. The subject will be invited to consume the pasta in 15 minutes while sipping 200 cc of mineral water at the same time. Blood samples for the determination of blood sugar and insulin will be collected at time 0, and then at 15, 30, 45, 60, 90 and 120 minutes from the start of the pasta intake.
After another 30 days, the third glucose response curve and all insulin will be performed on each subject, with the other modalities of the first two loading curves (this provides an average value of the subject's response to glucose over time).
Phase 3: Statistical processing of the results of phase 2 and determination of the glycemic index and insulinemic index for each type of pasta tested.
Phase 4: For each type of pasta tested, a detailed report will be drawn up, complete with graphs relating to the glycemic and insulinemic response for each subject. Each report will include the glycemic and insulinemic index values of the product concerned.
This will allow to determine which pasta format and which type of flour has the lowest glycemic and insulinemic index.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Dietary Supplement: lowest Glycemic Index for a selected type fo cereal productDetermination of Glycemic and Insulinemic curves under different alimentary intake |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects
- No carbohydrate intolerance or diabetes
Key exclusion criteria (1 listed)
- Intolerance ascertained to the products in study (celiac syndrome)
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 |
|---|---|---|
| lowest Glycemic Index for a selected type fo cereal productdetermination of lowest Glycemic Index for a selected type fo cereal product | Dietary supplement | Test arm |
Primary outcome
Glycemic Index determination
Time frame: 1 year
determination of the glycemic index for the product in study
1 secondary outcome
Insulinemic Index determination
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing lowest Glycemic Index for a selected type fo cereal product in people with Glycemic Index, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
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 1 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Maria Gabriella Dr Caruso, MD (+390804994651, gabriella.caruso@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Index determination (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2020.