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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01894438
First Posted: July 10, 2013
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Athens
Information provided by (Responsible Party):
Meropi Kontogianni, Harokopio University
  Purpose

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.


Condition Intervention
Non-alcoholic Fatty Liver Disease (NAFLD) Non-alcoholic Steatohepatitis (NASH) Behavioral: Mediterranean lifestyle Behavioral: Mediterranean Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of a Mediterranean Lifestyle Intervention on Biochemical and Clinical Characteristics of Patients With Non-alcoholic Fatty Liver Disease.

Resource links provided by NLM:


Further study details as provided by Meropi Kontogianni, Harokopio University:

Primary Outcome Measures:
  • Serum levels of alanine aminotransferase (ALT) [ Time Frame: Within 6 months ]
    Clinically useful reduction in ALT, defined as the restoration of ALT within normal limits or reduction of ALT in >50% of its initial value.


Secondary Outcome Measures:
  • Gamma-glutamyl transpeptidase (GGT) [ Time Frame: Within 6 months ]
    Restore of GGT levels within normal limits (i.e. GGT<30 IU/L).

  • Liver stiffness [ Time Frame: Within 6 months ]
    Improved liver stiffness as estimated with elastography.

  • Inflammatory and oxidative stress markers [ Time Frame: Within 6 months ]
    Improved inflammatory markers (TNF-a, IL-6, IL-8, adiponectin) and oxidative stress markers (ex vivo serum resistance to oxidation, measurement of the compounds that react with thiobarbituric acid-TBARS, activity of glutathione peroxidase) as well as lipid/glucose metabolism improvement (triglycerides, HDL, LDL, total cholesterol, insulin resistance index).


Enrollment: 63
Study Start Date: April 2013
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
This arm will receive written general advice for a healthy lifestyle.
Experimental: Mediterranean Diet Group
Mediterranean Diet Group participants will attend a comprehensive program,focusing on Mediterranean diet, comprising of seven 60-min group counseling sessions, conducted every two weeks for the first 2 months and every month for the following 4 months, until the 6-month evaluation.
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.
Experimental: Mediterranean Lifestyle Group
Mediterranean Lifestyle Group participants will attend a comprehensive program,focusing on Mediterranean lifestyle, comprising of seven 60-min group counseling sessions, conducted every two weeks for the first 2 months and every month for the following 4 months, until the 6-month evaluation.
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The inclusion criteria will be:

  • Participants aged 18-65 years old,
  • Participants with non-alcoholic fatty liver disease (NAFLD). NAFLD's diagnosis will be based on increased serum levels of alanine aminotransferase (ALT) above 1.5 times, with or without increased gamma-glutamyl transpeptidase (GGT) serum levels,
  • BMI >25 Kg/m2 (range 25-40 Kg/m2),
  • The presence of hepatic steatosis and absence of other causes of hepatic steatosis and hepatic failure.

Exclusion Criteria:

The exclusion criteria will be:

  • Detection of hepatitis B surface antigen (HBsAg) or antibodies against hepatitis C(anti-HCV) or antibodies against HIV,
  • Alcohol intake >210 or >140 gr per week for men or women, respectively,
  • Reception of potentially hepatotoxic drugs,
  • Presence of systemic disease with potential liver involvement,
  • Diabetes mellitus.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894438


Locations
Greece
Harokopio University
Kallithea, Attiki, Greece, 17671
Sponsors and Collaborators
Harokopio University
University of Athens
Investigators
Study Director: Meropi D. Kontogianni, PhD Harokopio University
  More Information

Responsible Party: Meropi Kontogianni, Lecturer of Clinical Nutrition, Harokopio University
ClinicalTrials.gov Identifier: NCT01894438     History of Changes
Other Study ID Numbers: LD-0098
First Submitted: July 3, 2013
First Posted: July 10, 2013
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available upon demand.

Keywords provided by Meropi Kontogianni, Harokopio University:
NAFLD
NASH
Mediterranean diet
Mediterranean lifestyle

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases