Clinical trial NCT02353416: Effect of Low-Glycemic Index Mediterranean Diet on AGEs
Official title: Effect of a Low Glycemic Index Mediterranean Diet on AGEs. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Insulin Resistance
Obesity
Cardiovascular Disease
Keywords: Mediterranean Diet
Low-Glycemic Index
AGEs
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not enrolled in the Nutriep cohort
* Pregnancy

Primary outcomes:
measure: Advanced glycation end products levels
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
state: BA
city: Castellana Grotte
country: Italy
facility: Laboratory of Epidemiology and Biostatistics
state: BA
Study officials:
affiliation: IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica
name: Giovanni Misciagna, MD, PhD
role: STUDY_DIRECTOR
affiliation: IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica
name: Rosa Reddavide, Bsc Sc
role: STUDY_CHAIR
References:
citation: Cozzolongo R, Osella AR, Elba S, Petruzzi J, Buongiorno G, Giannuzzi V, Leone G, Bonfiglio C, Lanzilotta E, Manghisi OG, Leandro G; NUTRIHEP Collaborating Group; Donnaloia R, Fanelli V, Mirizzi F, Parziale L, Crupi G, Detomaso P, Labbate A, Zizzari S, Depalma M, Polignano A, Lopinto D, Daprile G. Epidemiology of HCV infection in the general population: a survey in a southern Italian town. Am J Gastroenterol. 2009 Nov;104(11):2740-6. doi: 10.1038/ajg.2009.428. Epub 2009 Jul 28.
citation: Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.