Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease

Not Applicable

Completed

• Conditions: NAFLD
• Interventions: Behavioral: General Advice; Behavioral: Low Glycemic Index Mediterranean Diet

• Registration Number: NCT01798719
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet: Dietary Advice	General Advice	Some general dietary advice about healthy dietary components, servings size and frequency of servings
Low glycemic index Mediterranean Diet	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)

Primary Outcome Measures

Name	Time	Method
Non-alcoholic Fatty Liver Disease Ultrasonography Score	Six months	A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used

Trial Locations

Locations (1)

Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis; 🇮🇹 Castellana Grotte, BA, Italy