Response of NAFLD Patients to Mediterranean Diet

Harokopio University

Status: Completed

Conditions: Steatosis of Liver; NAFLD

Treatments: Other: Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03203486

09-ΣΥΝ-12-890

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Meditteranean Diet

Experimental group

Description:

NAFLD patients attended appointments with experienced dieticians to receive nutritional guidance based on a traditional Mediterranean Diet for 6 months.

Treatment:

Other: Mediterranean Diet