Healthy Subjects Clinical Trial
Official title:
Study on Glycemic and Insulin Index Values of Five Types of Pasta With Different Flour Content, and Egg Components
The glycemic index (GI) compares the plasma glucose response to a specific amount of
carbohydrates with the response induced by the same amount of carbohydrates from a standard
carbohydrate source, pure glucose in our case. The GI is defined as the incremental area
under the curve (iAUC) for blood glucose after consumption of a test food divided by the iAUC
of a reference food containing the same amount of carbohydrates. GI is based on the
physiologic functions of food carbohydrates rather than on their chemical structure, allowing
to a more accurate classification. Several studies found that the regular consumption of low
glycemic meals reduces the risk of developing diabetes, insulin-resistance, cardiovascular
and neoplastic diseases.
GI was originally developed for insulin-resistant subjects. The maintenance of stable blood
glucose levels is a challenge for people with diabetes and pre-diabetes and is also
beneficial for the general population, as reported by several studies.
Low-GI diets have been shown to:
- stabilize blood sugar levels
- improve body weight
- better control appetite
- improve memory
- reduce the risk of cardiovascular diseases
- reduce the risk of some forms of cancer According to Walter Willet, nutrition researcher
at the Harvard School of Public Health, an excess of sugars and refined starches
stimulates insulin hypersecretion, hunger pangs and frequent snacking, slowing down
lipid metabolism and making people physically less active.
This project aims to evaluate the glycemic index of five different types of pasta with the
same format, named "Fettuccine", but with different composition (the pasta format is related
to GI variations). The different types of pasta vary for flour and egg composition. However,
having the same format, the GI will change only in response to the percentage content of the
ingredients used to produce pasta. In particular, the aim is to measure egg's effect,
distinct in yolk and white, on the glycemic and insulin response of healthy subjects.
The five types of pasta to be tested are produced by the so called "La Campofilone" Company
(Ficiarà, Campofilone, Marche), a national excellence in the production of traditional egg.
Every pasta is designed and realized with the scientific support of two consultants: Prof.
Paolo De Cristofaro, endocrinologist, diabetologist and professor at the School of
Specialization in Food Science and Nutrition at the University of Chieti, and Prof. Giampiero
Sacchetti, biotechnologist at the Marche Polytechnic University. Specifically, the products
to be tested are:
1. Traditional Fettuccine, original recipe (8 eggs/kg flour) currently available on the
market;
2. Pasta with only 8 egg whites/kg flour;
3. Pasta with 4 eggs/kg flour;
4. Hyperproteic pasta (with added gluten and albumin);
5. Pasta with only 4 egg whites/kg flour.
Each phase of the project will be implemented in accordance with the Jenkins and Wolever
protocol (World Health Organization-Food and Agriculture Organization of the United
Nations,1998). 12 healthy subjects, aged 18-65 years, will be recruited. After a 10 to
12-hour overnight fasting period, standard food (a glucose solution) and food test (the
different types of fettuccine La Campofilone) will be administered to volunteers, organized
into groups of two or three people.
Both test food administrations and standard food administrations will take place on a
different day. The standard food consists of 50 g of glucose dissolved in oligomineral water,
the test food consists of a portion of pasta containing 50 g of available carbohydrates.
Blood samples for determination of glycemia and insulinemia will be taken at time 0 and then
at 15, 30, 45, 60, 90 and 120 minutes from the beginning of the test or standard food intake.
Three glucose response curves will be performed on each subject (this allows to obtain an
average value of the subject's response to glucose over time) while a single test with the
food to be tested will be done. Blood samples will be analyzed at the Service of Medical
Laboratory Analysis of the Hospital "S. De Bellis". Glucose and insulin values will be used
to calculate the glycemic and insulin index of each product. For each type of tested pasta, a
detailed report will be drawn up, complete with graphs of glycemic response for each subject.
Each report will include the glycemic and insulin index of the product under review.
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