Improvements in clinical characteristics of patients with non-alcoholic fatty liver disease, after an intervention based on the Mediterranean lifestyle: a randomised controlled clinical trial

Br J Nutr. 2018 Jul;120(2):164-175. doi: 10.1017/S000711451800137X.


Lifestyle interventions remain the cornerstone therapy for non-alcoholic fatty liver disease (NAFLD). This randomised controlled single-blind clinical trial investigated the effect of Mediterranean diet (MD) or Mediterranean lifestyle, along with weight loss, in NAFLD patients. In all, sixty-three overweight/obese patients (50 (sd 11) years, BMI=31·8 (sd 4·5) kg/m2, 68 % men) with ultrasonography-proven NAFLD (and elevated alanine aminotransferase (ALT) and/or γ-glutamyl transpeptidase (GGT) levels) were randomised to the following groups: (A) control group (CG), (B) Mediterranean diet group (MDG) or (C) Mediterranean lifestyle group (MLG). Participants of MDG and MLG attended seven 60-min group sessions for 6 months, aiming at weight loss and increasing adherence to MD. In the MLG, additional guidance for increasing physical activity and improving sleep habits were given. Patients in CG received only written information for a healthy lifestyle. At the end of 6 months, 88·8 % of participants completed the study. On the basis of intention-to-treat analysis, both MDG and MLG showed greater weight reduction and higher adherence to MD compared with the CG (all P<0·05) at the end of intervention. In addition, MLG increased vigorous exercise compared with the other two study groups (P<0·001) and mid-day rest/naps compared with CG (P=0·04). MLG showed significant improvements in ALT levels (i.e. ALT<40 U/l (P=0·03) and 50 % reduction of ALT levels (P=0·009)) and liver stiffness (P=0·004) compared with CG after adjusting for % weight loss and baseline values. MDG improved only liver stiffness compared with CG (P<0·001) after adjusting for the aforementioned variables. Small changes towards the Mediterranean lifestyle, along with weight loss, can be a treatment option for patients with NAFLD.

Keywords: ALT alanine aminotransferase; AST aspartate aminotransferase; CG control group; GGT γ-glutamyl transpeptidase; LSM reliable liver stiffness measurements; MD Mediterranean diet; MDG Mediterranean diet group; MET metabolic equivalents; MLG Mediterranean lifestyle group; NAFLD non-alcoholic fatty liver disease; NFS NAFLD fibrosis score; Intervention; Mediterranean diet; Mediterranean lifestyle; Non-alcoholic fatty liver disease; Sleep; Weight loss.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Alanine Transaminase / blood
  • Anthropometry
  • Body Weight
  • Diet, Mediterranean
  • Elasticity Imaging Techniques
  • Exercise
  • Female
  • Fibrosis
  • Humans
  • Life Style*
  • Liver / pathology
  • Male
  • Middle Aged
  • Non-alcoholic Fatty Liver Disease / epidemiology
  • Non-alcoholic Fatty Liver Disease / therapy*
  • Obesity / therapy*
  • Outpatients
  • Overweight
  • Patient Compliance
  • Single-Blind Method
  • Sleep
  • Weight Loss
  • Young Adult
  • gamma-Glutamyltransferase / blood


  • gamma-Glutamyltransferase
  • Alanine Transaminase