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

NCT01894438 | Completed

• 1 other identifier: LD-0098
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

NAFLD; NASH; Mediterranean diet; Mediterranean lifestyle

Outcome Measures

Primary Outcomes (1)

• Serum levels of alanine aminotransferase (ALT)

  Clinically useful reduction in ALT, defined as the restoration of ALT within normal limits or reduction of ALT in \>50% of its initial value.

  Within 6 months

Secondary Outcomes (3)

• Gamma-glutamyl transpeptidase (GGT)

  Within 6 months

• Liver stiffness

  Within 6 months

• Inflammatory and oxidative stress markers

  Within 6 months

Study Arms (3)

Control Group

NO INTERVENTION

This arm will receive written general advice for a healthy lifestyle.

Mediterranean Diet Group

EXPERIMENTAL

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

Mediterranean Lifestyle Group

EXPERIMENTAL

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

Interventions

Mediterranean lifestyle BEHAVIORAL

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.

Mediterranean Lifestyle Group

Mediterranean Diet BEHAVIORAL

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.

Mediterranean Diet Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harokopio University: lead
• University of Athens: collaborator

Study Sites (1)

Harokopio University

Kallithea, Attica, 17671, Greece

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Meropi D. Kontogianni, PhD

  Harokopio University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Nutrition

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)