NCT02353416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

January 28, 2015

Last Update Submit

January 30, 2015

Conditions

Type 2 DiabetesInsulin ResistanceObesityCardiovascular Disease

Keywords

Mediterranean DietLow-Glycemic IndexAGEs

Outcome Measures

Primary Outcomes (1)

  • Advanced glycation end products levels

    Blood and skin levels of AGEs

    Six months

Study Arms (2)

INRAM guidelines' diet

PLACEBO COMPARATOR

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

Low Glycemic Index Mediterranean Diet

ACTIVE COMPARATOR

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

Interventions

Low Glycemic Index Mediterranean DietBEHAVIORAL

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

Low Glycemic Index Mediterranean Diet
INRAM Guidelines' dietOTHER

Prescription of INRAM guidelines' diet

INRAM guidelines' diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not enrolled in the Nutriep cohort
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis

Castellana Grotte, BA, 70013, Italy

Location

Laboratory of Epidemiology and Biostatistics

Castellana Grotte, BA, 70013, Italy

Location

Related Publications (2)

  • 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.

    PMID: 19638964BACKGROUND

  • 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.

    PMID: 32476140DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceObesityCardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giovanni Misciagna, MD, PhD

    IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica

    STUDY DIRECTOR

  • Rosa Reddavide, Bsc Sc

    IRCCS Saverio de Bellis. Laboratorio di Epidemiologia e Biostatistica

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head. Laboratory of Epidemiology and Biostatistics

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 2, 2015

Study Start

February 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

IT(2)