Glycemic Index of Traditional Egg Pasta

NCT03298529 | Completed

• 1 other identifier: IG2017C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glycemic Response; Insulinemic Response; Healthy Subjects

Keywords

Glycemic index; Insulinemic index; Traditional egg pasta

Outcome Measures

Primary Outcomes (1)

• glicemic index

  to measure glicemic index of each type of pasta

  6 months

Study Arms (5)

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.

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.

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.

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.

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.

Other: glucose solution; Other: Pasta with only four egg whites/kg flour

Interventions

glucose solution OTHER

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%

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 pasta OTHER

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

Traditional egg pasta

Pasta with eight egg whites/kg flour OTHER

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 only eight egg whites/kg flour

Pasta with four eggs/kg flour OTHER

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

Pasta with four eggs/kg flour

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

Hyperproteic pasta (with added gluten and albumin)

Pasta with only four egg whites/kg flour OTHER

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

Pasta with only four egg whites/kg flour

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

• pregnancy and breast feeding
• athletes
• current pharmacological therapy or pharmacological therapy interrupted less than 3 months before recruitment.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

Azienda ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Castellana Grotte, Bari, 70013, Italy

Location

MeSH Terms

Interventions

Albumins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology, Director of the Service of Clinical Nutrition

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: October 2, 2017
• Study Start: September 1, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 25, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

IT (1)