Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease (Nutriepa)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

ClinicalTrials.gov Identifier:

NCT01798719

First received: February 22, 2013

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Purpose

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

Condition	Intervention
NAFLD	Behavioral: Low Glycemic Index Mediterranean Diet Behavioral: General Advice

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:

Primary Outcome Measures:

Non-alcoholic Fatty Liver Disease Ultrasonography Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used

Enrollment:	50
Study Start Date:	February 2011
Study Completion Date:	November 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Diet: Dietary Advice Some general dietary advice about healthy dietary components, servings size and frequency of servings	Behavioral: General Advice Only general advice about diet
Experimental: Low glycemic index Mediterranean Diet 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 A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)

Detailed Description:

The majority of NAFLD patients are characterized by high body mass index, insulin resistance and they show a remarkably higher energy intake in comparison to individuals without hepatic steatosis. Several authors have proposed dietary weight loss strategies to ameliorate or reverse fatty liver because of the potential role of weight loss on the supposed risk factors of liver injury, mainly insulin resistance, free fatty acid levels, and pro-inflammatory and profibrotic adipokines. There are no definite data regarding how much and how rapidly weight loss should be to have the more favorable effects, but in obese children, the larger the weight loss, the larger the decrease of liver enzyme levels and the lower the prevalence of NAFLD. The American Gastroenterological Association recommends a weight loss target of 10% of baseline. A loss of at least 10% of body weight in obese patients is associated with a normalization of previously abnormal liver function tests as well as decreased hepatomegaly, but even a moderate weight loss (approximately 6% of baseline weight) can improve insulin resistance and intrahepatic liver content.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Middle NAFLD
Not enrolled in the Nutriep cohort
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798719

Locations

Italy
Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
Castellana Grotte, BA, Italy, 70013

Sponsors and Collaborators

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Investigators

Principal Investigator:	Alberto R Osella, MD, PhD	IRCCS Saverio de Bellis
Study Director:	Giovanni Misciagna, MD, PhD	IRCCS Saverio de Bellis

More Information

Publications:

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.

Responsible Party:	Alberto R Osella, Senior Researcher, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier:	NCT01798719 History of Changes
Other Study ID Numbers:	EPINUT3
Study First Received:	February 22, 2013
Last Updated:	February 26, 2013
Health Authority:	Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:

NAFLD
Clinical Trial
Mediterranean Diet
Low Glycemic Index

Additional relevant MeSH terms:

Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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