Clinical Trials Directory

Trials / Completed

CompletedNCT02353416

Effect of Low-Glycemic Index Mediterranean Diet on AGEs

Effect of a Low Glycemic Index Mediterranean Diet on AGEs. A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLow Glycemic Index Mediterranean DietPrescription of a Low Glycemic Index (less than 50) Mediterranean Diet with no more than 10% of total daily calories coming from saturated fats, high in monounsaturated fatty acids (MUFA) from olive oil and omega-3 polyunsaturated fatty acids (ω3PUFA), from both plant and marine sources
OTHERINRAM Guidelines' dietPrescription of INRAM guidelines' diet

Timeline

Start date
2011-02-01
Primary completion
2011-10-01
Completion
2011-11-01
First posted
2015-02-02
Last updated
2015-02-02

Locations

2 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT02353416. Inclusion in this directory is not an endorsement.