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

February 22, 2013
February 26, 2013
February 2011
October 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01798719 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease
Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
NAFLD
  • Behavioral: Low Glycemic Index Mediterranean Diet
    A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)
  • Behavioral: General Advice
    Only general advice about diet
  • Placebo Comparator: Diet: Dietary Advice
    Some general dietary advice about healthy dietary components, servings size and frequency of servings
    Intervention: Behavioral: General Advice
  • 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)
    Intervention: Behavioral: Low Glycemic Index Mediterranean Diet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01798719
EPINUT3
Yes
Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Not Provided
Principal Investigator: Alberto R Osella, MD, PhD IRCCS Saverio de Bellis
Study Director: Giovanni Misciagna, MD, PhD IRCCS Saverio de Bellis
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP