Effect of Low-Glycemic Index Mediterranean Diet on AGEs

Not Applicable

Completed

• Conditions: Insulin Resistance; Cardiovascular Disease; Obesity; Type 2 Diabetes
• Interventions: Behavioral: Low Glycemic Index Mediterranean Diet; Other: INRAM Guidelines' diet

• Registration Number: NCT02353416
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2015-01
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-30
• Last Update Submitted: 2015-01-30
• Study First Posted: 2015-02-02
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Not enrolled in the Nutriep cohort
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Glycemic Index Mediterranean Diet	Low Glycemic Index Mediterranean Diet	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)
INRAM guidelines' diet	INRAM Guidelines' diet	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.

Primary Outcome Measures

Name	Time	Method
Advanced glycation end products levels	Six months	Blood and skin levels of AGEs

Trial Locations

Locations (2)

Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis; 🇮🇹 Castellana Grotte, BA, Italy

Laboratory of Epidemiology and Biostatistics; 🇮🇹 Castellana Grotte, BA, Italy