Clinical trial NCT03203486: Response of NAFLD Patients to Mediterranean Diet
Official title: The Effectiveness of a Mediterranean Diet Intervention in NAFLD Clinical Course
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Steatosis of Liver
Keywords: NAFLD
no fibrosis
Mediterranean diet
STAT3
GCKR
visfatin
oxidized LDL
fasting glucose
inflammation
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: Greek Secretariat for Research and Technology
First posted: 2017-06-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non-randomised, open-label study
Primary purpose: OTHER

Brief summary: The effects of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile were also investigated.

Detailed description: Diet is a modifiable key factor targeted in prevention and management of non-alcoholic fatty liver disease (NAFLD). The aim of the study is to investigate the effect of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile are investigated. In this non-randomised, open-label study, 44 untreated NAFLD patients with non significant fibrosis receive nutritional counsel to increase adherence to MedDiet. Adherence to MedDiet is estimated with MedDietScore. Furthermore, genotyping of STAT3 rs2293152 and GCKR rs1260326 single nucleotide polymorphisms takes place.

Eligibility criteria: Inclusion Criteria:

* men and women \>18y of age, no change in body weight (BW) for the last 6 months prior to the trial and body mass index (BMI) \>25 kg/m2.

Exclusion Criteria:

* the presence of chronic viral hepatitis, the presence of congenital or acquired liver disease, the history of prior exposure to hepatotoxic drugs, the evidence of hepatic cirrhosis, ultrasonography values less than 1Hz, bariatric surgery, daily consumption of ethanol more than 20g for women and more than 30g for men for over 6 months during the last 5 years, any medication effective on fatty liver disease introduced \<6 months prior to or during the trial, the co-presence of a life-threatening disease, psychiatric disorders impairing the patient's ability to provide written informed consent, age\>65 years, pregnant or lactating women, subjects supplemented with omega-3 polyunsaturated fatty acids, probiotics/synbiotics, antioxidant vitamins and/or phytochemicals, any planned, structured and repetitive physical activity. Patients with any medication change during the trial were excluded from analysis.

Primary outcomes:
measure: Regulation of hepatic steatosis
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: Adherence to MedDiet
timeFrame: Change from Baseline to 6 months
measure: Regulation of visfatin
timeFrame: Change from Baseline to 6 months
measure: Regulation of oxLDL
timeFrame: Change from Baseline to 6 months
measure: Association of single nucleotide polymorphisms to response to dietary treatment
timeFrame: Change from Baseline to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Harokopio University of Athens
name: Andriana C Kaliora, PhD
role: PRINCIPAL_INVESTIGATOR
References: