Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease (Nutriepa)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier:
NCT01798719
First received: February 22, 2013
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
NAFLD
Behavioral: Low Glycemic Index Mediterranean Diet
Behavioral: General Advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:

Primary Outcome Measures:
  • Non-alcoholic Fatty Liver Disease Ultrasonography Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
    A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used


Enrollment: 50
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Diet: Dietary Advice
Some general dietary advice about healthy dietary components, servings size and frequency of servings
Behavioral: General Advice
Only general advice about diet
Experimental: 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)
Behavioral: Low Glycemic Index Mediterranean Diet
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798719

Locations
Italy
Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
Castellana Grotte, BA, Italy, 70013
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Investigators
Principal Investigator: Alberto R Osella, MD, PhD IRCCS Saverio de Bellis
Study Director: Giovanni Misciagna, MD, PhD IRCCS Saverio de Bellis
  More Information

Publications:
Responsible Party: Alberto R Osella, Senior Researcher, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier: NCT01798719     History of Changes
Other Study ID Numbers: EPINUT3
Study First Received: February 22, 2013
Last Updated: February 26, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:
NAFLD
Clinical Trial
Mediterranean Diet
Low Glycemic Index

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014