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Completed

NCT Number: NCT02353416

Effect of Low-Glycemic Index Mediterranean Diet on AGEs

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Epidemiology and Biostatistics, Castellana Grotte, BA, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not enrolled in the Nutriep cohort
  • Pregnancy

Treatment and study plan

Low Glycemic Index Mediterranean Diet

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

INRAM Guidelines' diet

Other

Prescription of INRAM guidelines' diet

Primary outcomes

  1. Advanced glycation end products levels

    Time frame: Six months

    Blood and skin levels of AGEs

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Official study title

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

Acronym: Nutri_AGEs

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2015
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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