Effect of Low-Glycemic Index Mediterranean Diet on AGEs (Nutri_AGEs)
Primary Purpose
Type 2 Diabetes, Insulin Resistance, Obesity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Low Glycemic Index Mediterranean Diet
INRAM Guidelines' diet
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Mediterranean Diet, Low-Glycemic Index, AGEs
Eligibility Criteria
Inclusion Criteria:
- Subject enrolled in the Nutriep cohort assembled in 2005-2007
Exclusion Criteria:
- Not enrolled in the Nutriep cohort
- Pregnancy
Sites / Locations
- Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
- Laboratory of Epidemiology and Biostatistics
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
INRAM guidelines' diet
Low Glycemic Index Mediterranean Diet
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
Advanced glycation end products levels
Blood and skin levels of AGEs
Secondary Outcome Measures
Full Information
NCT ID
NCT02353416
First Posted
January 28, 2015
Last Updated
January 30, 2015
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
1. Study Identification
Unique Protocol Identification Number
NCT02353416
Brief Title
Effect of Low-Glycemic Index Mediterranean Diet on AGEs
Acronym
Nutri_AGEs
Official Title
Effect of a Low Glycemic Index Mediterranean Diet on AGEs. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Insulin Resistance, Obesity, Cardiovascular Disease
Keywords
Mediterranean Diet, Low-Glycemic Index, AGEs
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INRAM guidelines' diet
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Low Glycemic Index Mediterranean Diet
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index Mediterranean Diet
Intervention Description
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
Other
Intervention Name(s)
INRAM Guidelines' diet
Intervention Description
Prescription of INRAM guidelines' diet
Primary Outcome Measure Information:
Title
Advanced glycation end products levels
Description
Blood and skin levels of AGEs
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject enrolled in the Nutriep cohort assembled in 2005-2007
Exclusion Criteria:
Not enrolled in the Nutriep cohort
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Misciagna, MD, PhD
Organizational Affiliation
IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rosa Reddavide, Bsc Sc
Organizational Affiliation
IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica
Official's Role
Study Chair
Facility Information:
Facility Name
Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
City
Castellana Grotte
State/Province
BA
ZIP/Postal Code
70013
Country
Italy
Facility Name
Laboratory of Epidemiology and Biostatistics
City
Castellana Grotte
State/Province
BA
ZIP/Postal Code
70013
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19638964
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.
Results Reference
background
PubMed Identifier
32476140
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.
Results Reference
derived
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Effect of Low-Glycemic Index Mediterranean Diet on AGEs
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