- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02353416
Effect of Low-Glycemic Index Mediterranean Diet on AGEs (Nutri_AGEs)
Effect of a Low Glycemic Index Mediterranean Diet on AGEs. A Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
BA
-
Castellana Grotte, BA, Italy, 70013
- Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
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Castellana Grotte, BA, Italy, 70013
- Laboratory of Epidemiology and Biostatistics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject enrolled in the Nutriep cohort assembled in 2005-2007
Exclusion Criteria:
- Not enrolled in the Nutriep cohort
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Advanced glycation end products levels
Time Frame: Six months
|
Blood and skin levels of AGEs
|
Six months
|
Collaborators and Investigators
Investigators
- 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 and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nutri_AGEs
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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