Effect of Low-Glycemic Index Mediterranean Diet on AGEs

NCT ID: NCT02353416

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-11-30

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.

Conditions

Type 2 Diabetes; Insulin Resistance; Obesity; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

INRAM Guidelines' diet

Intervention Type: OTHER

Prescription of INRAM guidelines' 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)

Group Type: ACTIVE_COMPARATOR

Low Glycemic Index Mediterranean Diet

Intervention Type: BEHAVIORAL

Prescription 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

Interventions

Low Glycemic Index Mediterranean Diet

Prescription 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

Intervention Type: BEHAVIORAL

INRAM Guidelines' diet

Prescription of INRAM guidelines' diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Not enrolled in the Nutriep cohort
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role: lead

Responsible Party

Alberto R Osella

Head. Laboratory of Epidemiology and Biostatistics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Misciagna, MD, PhD

Role: STUDY_DIRECTOR

IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica

Rosa Reddavide, Bsc Sc

Role: STUDY_CHAIR

IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica

Locations

Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis

Castellana Grotte, BA, Italy

Laboratory of Epidemiology and Biostatistics

Castellana Grotte, BA, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 19638964 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32476140 (View on PubMed)

Other Identifiers

Nutri_AGEs

Identifier Type: -

Identifier Source: org_study_id