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OpenTrials
Completed

NCT Number: NCT01798719

Effect of Mediterranean Diet on 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

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis

Castellana Grotte, BA, 70013, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Glycemic Index Mediterranean Diet

Behavioral

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)

General Advice

Behavioral

Only general advice about diet

Primary outcomes

  1. Non-alcoholic Fatty Liver Disease Ultrasonography Score

    Time frame: Six months

    A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Official study title

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

Acronym: Nutriepa

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 26, 2013
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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