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Effect of Low-Glycemic Index Mediterranean Diet on AGEs (Nutri_AGEs)

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ClinicalTrials.gov Identifier: NCT02353416
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Alberto R Osella, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Insulin Resistance Obesity Cardiovascular Disease Behavioral: Low Glycemic Index Mediterranean Diet Other: INRAM Guidelines' diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Low Glycemic Index Mediterranean Diet on AGEs. A Randomized Clinical Trial
Study Start Date : February 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.
Other: INRAM Guidelines' diet
Prescription of INRAM guidelines' diet

Active Comparator: 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)
Behavioral: 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




Primary Outcome Measures :
  1. Advanced glycation end products levels [ Time Frame: Six months ]
    Blood and skin levels of AGEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not enrolled in the Nutriep cohort
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353416


Locations
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Italy
Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
Castellana Grotte, BA, Italy, 70013
Laboratory of Epidemiology and Biostatistics
Castellana Grotte, BA, Italy, 70013
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Investigators
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Study Director: Giovanni Misciagna, MD, PhD IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica
Study Chair: Rosa Reddavide, Bsc Sc IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alberto R Osella, Head. Laboratory of Epidemiology and Biostatistics, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier: NCT02353416    
Other Study ID Numbers: Nutri_AGEs
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Keywords provided by Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:
Mediterranean Diet
Low-Glycemic Index
AGEs
Additional relevant MeSH terms:
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Insulin Resistance
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases