Glycemic Index Clinical Trial
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.
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.
;
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