Glycemic ResponseNCT03298529
Glycemic Index of Traditional Egg Pasta
A study testing glucose solution, Traditional egg pasta and Pasta with eight egg whites/kg flour in people with Glycemic Response and Insulinemic Response, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response, Insulinemic Response, Healthy Subjects
- What is being tested?
- glucose solution, Traditional egg pasta and Pasta with eight egg whites/kg flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to 25 Sep 2017
- 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 volunteers
Who cannot join
- pregnancy and breast feeding
- athletes
- current pharmacological therapy or pharmacological therapy interrupted less than 3 months before recruitment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte, Bari, 70013
About this study
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.
Read more
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.
Read the detailed description
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:
- Traditional Fettuccine, original recipe (8 eggs/kg flour) currently available on the market;
- Pasta with only 8 egg whites/kg flour;
- Pasta with 4 eggs/kg flour;
- Hyperproteic pasta (with added gluten and albumin);
- 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.
- Conditions
- Glycemic Response, Insulinemic Response, Healthy Subjects
- Being tested
- glucose solution, Traditional egg pasta, Pasta with eight egg whites/kg flour, Pasta with four eggs/kg flour, Hyperproteic pasta (with added gluten and albumin)
- Keywords
- Glycemic index, Insulinemic index, Traditional egg pasta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose solutionOther
12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume standard food, a glucose solution at 50%
Traditional egg pastaOther
12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume traditional pasta, with 8 eggs/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
Pasta with eight egg whites/kg flourOther
12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with eight egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
Pasta with four eggs/kg flourOther
12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
Hyperproteic pasta (with added gluten and albumin)Other
12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with added gluten and albumin.The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
Pasta with only four egg whites/kg flourOther
12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
| Study group | Role | What they receive |
|---|---|---|
| Traditional egg pasta | Experimental | Traditional egg pasta. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta made with 8 eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. Receives: Other: glucose solution; Other: Traditional egg pasta |
| Pasta with only eight egg whites/kg flour | Experimental | Pasta with only eight egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with only eight egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. Receives: Other: glucose solution; Other: Pasta with eight egg whites/kg flour |
| Pasta with four eggs/kg flour | Experimental | Pasta with four eggs/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with four eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. Receives: Other: glucose solution; Other: Pasta with four eggs/kg flour |
| Hyperproteic pasta (with added gluten and albumin) | Experimental | Hyperproteic pasta (with added gluten and albumin). 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with added gluten and albumin. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. Receives: Other: glucose solution; Other: Hyperproteic pasta (with added gluten and albumin) |
| Pasta with only four egg whites/kg flour | Experimental | Pasta with only four egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with only four egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. Receives: Other: glucose solution; Other: Pasta with only four egg whites/kg flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
glicemic index
to measure glicemic index of each type of pasta
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Sep 2017
- Primary completion15 Sep 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gioacchino Leandro, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298529
- Sponsor's protocol ID
- IG2017C
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Glycemic and Insulin Index Values of Five Types of Pasta With Different Flour Content, and Egg Components
- ClinicalTrials.gov ID
- NCT03298529
- Acronym / sponsor ID
- IG2017C
- Conditions
- Glycemic Response, Insulinemic Response, Healthy Subjects
- Keywords
- Glycemic index, Insulinemic index, Traditional egg pasta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 2 Oct 2017 (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 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.
Detailed description
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:
- Traditional Fettuccine, original recipe (8 eggs/kg flour) currently available on the market;
- Pasta with only 8 egg whites/kg flour;
- Pasta with 4 eggs/kg flour;
- Hyperproteic pasta (with added gluten and albumin);
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Traditional egg pasta | Experimental | Other: glucose solution, Other: Traditional egg pastaTraditional egg pasta. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta made with 8 eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. |
| Pasta with only eight egg whites/kg flour | Experimental | Other: glucose solution, Other: Pasta with eight egg whites/kg flourPasta with only eight egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with only eight egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. |
| Pasta with four eggs/kg flour | Experimental | Other: glucose solution, Other: Pasta with four eggs/kg flourPasta with four eggs/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with four eggs/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. |
| Hyperproteic pasta (with added gluten and albumin) | Experimental | Other: glucose solution, Other: Hyperproteic pasta (with added gluten and albumin)Hyperproteic pasta (with added gluten and albumin). 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with added gluten and albumin. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. |
| Pasta with only four egg whites/kg flour | Experimental | Other: glucose solution, Other: Pasta with only four egg whites/kg flourPasta with only four egg whites/kg flour. 12 healthy subjects, after a 10 to 12-hour overnight fasting period, will assume "fettuccine" pasta with only four egg whites/kg flour. The serving size is calculated to contain 50 g of carbohydrates according to nutritional analysis of the product. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (3 listed)
- pregnancy and breast feeding
- athletes
- current pharmacological therapy or pharmacological therapy interrupted less than 3 months before recruitment.
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 |
|---|---|---|
| glucose solution12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume standard food, a glucose solution at 50% | Other | Hyperproteic pasta (with added gluten and albumin), Pasta with four eggs/kg flour, Pasta with only eight egg whites/kg flour, Pasta with only four egg whites/kg flour, Traditional egg pasta |
| Traditional egg pasta12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume traditional pasta, with 8 eggs/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label | Other | Traditional egg pasta |
| Pasta with eight egg whites/kg flour12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with eight egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label | Other | Pasta with only eight egg whites/kg flour |
| Pasta with four eggs/kg flour12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label | Other | Pasta with four eggs/kg flour |
| Hyperproteic pasta (with added gluten and albumin)12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with added gluten and albumin.The serving size must contain 50 g of carbohydrates, calculated according to nutritional label | Other | Hyperproteic pasta (with added gluten and albumin) |
| Pasta with only four egg whites/kg flour12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label | Other | Pasta with only four egg whites/kg flour |
Primary outcome
glicemic index
Time frame: 6 months
to measure glicemic index of each type of pasta
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose solution, Traditional egg pasta and Pasta with eight egg whites/kg flour in people with Glycemic Response and Insulinemic Response, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 2 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glicemic index (time frame: 6 months). 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 2 Oct 2017.