Clinical trial NCT01798719: Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease
Official title: Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Keywords: NAFLD
Clinical Trial
Mediterranean Diet
Low Glycemic Index
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Non-alcoholic Fatty Liver Disease Ultrasonography Score
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
state: BA
Study officials:
affiliation: IRCCS Saverio de Bellis
name: Alberto R Osella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Saverio de Bellis
name: Giovanni Misciagna, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.