Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease

Conditions
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NAFLD

Intervention / Treatment
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* Behavioral: Low Glycemic Index Mediterranean Diet
* Behavioral: General Advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Diet: Dietary Advice<br>Some general dietary advice about healthy dietary components, servings size and frequency of servings | Behavioral: General Advice<br>* Only general advice about diet<br>|
| Experimental: Low glycemic index Mediterranean Diet<br>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<br>* A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-alcoholic Fatty Liver Disease Ultrasonography Score | A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, Clinical Trial, Mediterranean Diet, Low Glycemic Index