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Mediterranean Lifestyle Intervention in Patients With Non-alcoholic Fatty Liver Disease

NCT01894438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2017-08-03

No results posted yet for this study

Summary

Non-alcoholic fatty liver disease (NAFLD) is considered as the hepatic manifestation of the metabolic syndrome. NAFLD is a pathologic condition which involves both hepatic steatosis and non alcoholic steatohepatitis (NASH), as the result of fat accumulation in the liver (liver fat \>5-10% of liver weight), not due to excess alcohol consumption or other causes of steatosis.

At present, no medication or surgical procedure has been approved for treating NAFLD and lifestyle modifications remain the cornerstone therapy targeting both at weight reduction for overweight subjects and at prevention of overweight for the normal weight individuals. Given that a Mediterranean dietary pattern has a beneficial effect both on the prevention and the resolution of the metabolic syndrome, the main aim of the present study is to implement and evaluate the potential benefits of an intervention based on the Mediterranean lifestyle in a sample of patients with NAFLD.

Conditions

  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Non-alcoholic Steatohepatitis (NASH)

Interventions

BEHAVIORAL

Mediterranean lifestyle

Counseling will be based on the goal setting theory. Motivational and behavioral strategies will be also used. In the Mediterranean lifestyle group culinary practices, seasonality, and locality of food products, socialization during meals, rest during the day, as well as the adoption of an active living will be additionally addressed.

BEHAVIORAL

Mediterranean Diet

Counseling will be based on the goal setting theory. Motivational and behavioral strategies will be also used. In the Mediterranean diet group, all food groups of the Mediterranean diet will be targeted.

Sponsors & Collaborators

  • University of Athens

    collaborator OTHER

  • Harokopio University

    lead OTHER

Principal Investigators

  • Meropi D. Kontogianni, PhD · Harokopio University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01894438 on ClinicalTrials.gov