NCT01798719

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated with the metabolic syndrome. As the disease stems from excess calorie intake and lack of physical activity, the correction of unhealthy lifestyles is the background of any prevention and treatment strategy

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

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

February 22, 2013

Last Update Submit

February 26, 2013

Conditions

NAFLD

Keywords

NAFLDClinical TrialMediterranean DietLow Glycemic Index

Outcome Measures

Primary Outcomes (1)

  • Non-alcoholic Fatty Liver Disease Ultrasonography Score

    A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used

    Six months

Study Arms (2)

Diet: Dietary Advice

PLACEBO COMPARATOR

Some general dietary advice about healthy dietary components, servings size and frequency of servings

Behavioral: General Advice

Low glycemic index Mediterranean Diet

EXPERIMENTAL

Low glycemic index Mediterranean Diet prescription 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

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)

Low glycemic index Mediterranean Diet
General AdviceBEHAVIORAL

Only general advice about diet

Diet: Dietary Advice

Eligibility Criteria

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

You may qualify if:

  • Subject enrolled in the cohort Nutriep assembled in 2005-2007
  • Moderate or severe NAFLD

You may not qualify if:

  • Middle NAFLD
  • Not enrolled in the Nutriep cohort
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis

Castellana Grotte, BA, 70013, Italy

Location

Related Publications (3)

  • 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

  • Misciagna G, Del Pilar Diaz M, Caramia DV, Bonfiglio C, Franco I, Noviello MR, Chiloiro M, Abbrescia DI, Mirizzi A, Tanzi M, Caruso MG, Correale M, Reddavide R, Inguaggiato R, Cisternino AM, Osella AR. Effect of a Low Glycemic Index Mediterranean Diet on Non-Alcoholic Fatty Liver Disease. A Randomized Controlled Clinici Trial. J Nutr Health Aging. 2017;21(4):404-412. doi: 10.1007/s12603-016-0809-8.

    PMID: 28346567DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Alberto R Osella, MD, PhD

    IRCCS Saverio de Bellis

    PRINCIPAL INVESTIGATOR

  • Giovanni Misciagna, MD, PhD

    IRCCS Saverio de Bellis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

February 22, 2013

First Posted

February 26, 2013

Study Start

February 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

IT(1)