Mediterranean Lifestyle Intervention in Patients With Non-alcoholic Fatty Liver Disease
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.
|Non-alcoholic Fatty Liver Disease (NAFLD) Non-alcoholic Steatohepatitis (NASH)||Behavioral: Mediterranean lifestyle Behavioral: Mediterranean Diet|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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.|
- 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.
- Serum levels of alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT) [ Time Frame: Within 6 months ]Normal serum levels of alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (GGT).
- Liver stiffness [ Time Frame: Within 6 months ]Improved liver stiffness as estimated with elastography.
- Histological disease activity [ Time Frame: Within 12 months ]Improvement of histological disease activity for patients who will rerun the liver biopsy after one year of the study entry.
- 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).
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01894438
|Contact: Meropi D. Kontogianni, PhDemail@example.com|
|Contact: Christina N. Katsagoni, MScfirstname.lastname@example.org|
|Kallithea, Attiki, Greece, 17671|
|Contact: Meropi D. Kontogianni, Phd 00302109549359 email@example.com|
|Principal Investigator: Meropi D. Kontogianni, PhD|
|Study Director:||Meropi D. Kontogianni, PhD||Harokopio University|