Effect of Low-Glycemic Index Mediterranean Diet on AGEs (Nutri_AGEs)

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Status: Completed

Conditions: Insulin Resistance; Obesity; Type 2 Diabetes; Cardiovascular Disease

Treatments: Other: INRAM Guidelines' diet; Behavioral: Low Glycemic Index Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02353416

Nutri_AGEs

Details and patient eligibility

About

Advanced glycation end products (AGE) result from a chemical reaction between the carbonyl group of reducing sugar and the nucleophilic NH2 of a free amino acid or a protein; lysine and arginine being the main reactive amino acids on proteins. Following this first step, a molecular rearrangement occurs, rearrangement of Amadori resulting to the formation of Maillard products.

Full description

Specialized receptors (RAGE, Galectin 3...) bind AGE. The binding to the receptor causes the formation of free radicals, which have a deleterious effect because they are powerful oxidizing agents, but also play the role of intracellular messenger, altering the cell functions.

This role is especially true at the level of endothelial cells as the attachment of AGE to RAGE receptor causes an increase in vascular permeability. AGE binding to endothelium RAGE and to monocytes-macrophages, led to the production of cytokines, growth factors, to the expression of adhesion molecules, and the production of procoagulant activity. Increased permeability, facilitation of leukocyte migration, the production of reactive oxygen species, cytokines and VEGF suggest that the AGE could be an element of a cascade of reactions responsible for the diabetic angiopathy and vascular damages observed during aging and chronic renal failure. Recently, It's been proposed that balanced diets can limit the deleterious effect of AGE. For these reasons, the interest in preventive approaches complementary or alternative to cholesterol reduction should be one of the main objectives of cardiovascular research in the years to come. Already in the '70s the very low incidence of atherosclerotic diseases in Mediterranean countries (Greece and Southern Italy) and the importance of the "dietary factor" in such protection were noticed. Diets for people in these countries are, among other components, very rich in oleic acid, the main constituent of olive oil, with about 29% of daily caloric intake derived from monounsaturated fatty acids. Aim of this trial is to estimate the effect of a Low Glycemic Index Mediterranean Diet on AGE products.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject enrolled in the Nutriep cohort assembled in 2005-2007

Exclusion criteria

• Not enrolled in the Nutriep cohort
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

INRAM guidelines' diet

Placebo Comparator group

Description:

Intervention in this arm consists in some general dietary advice about healthy dietary components, serving size and frequency of servings following the Italian official guidelines.

Treatment:

Other: INRAM Guidelines' diet

Low Glycemic Index Mediterranean Diet

Active Comparator group

Description:

Intervention in this arm consists in a Low Glycemic Index Mediterranean Diet with indication about type of foods than can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)

Treatment:

Behavioral: Low Glycemic Index Mediterranean Diet