Clinical Trials Directory

Trials / Completed

CompletedNCT01798719

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLow Glycemic Index Mediterranean DietA list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)
BEHAVIORALGeneral AdviceOnly general advice about diet

Timeline

Start date
2011-02-01
Primary completion
2011-10-01
Completion
2011-11-01
First posted
2013-02-26
Last updated
2013-02-27

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01798719. Inclusion in this directory is not an endorsement.