Response of NAFLD Patients to Mediterranean Diet

Not Applicable

Completed

• Conditions: Steatosis of Liver; NAFLD
• Interventions: Other: Mediterranean Diet

• Registration Number: NCT03203486
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Status Verified: 2017-06
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-27
• Last Update Submitted: 2017-06-27
• Study First Posted: 2017-06-29
• Last Update Posted: 2017-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Regulation of hepatic steatosis	Change from Baseline to 6 months	A decrease in liver fat

Secondary Outcome Measures

Name	Time	Method
Adherence to MedDiet	Change from Baseline to 6 months	Increase in MedDietScore
Association of single nucleotide polymorphisms to response to dietary treatment	Change from Baseline to 6 months	Decrease in visfatin in carriers of the risk allele
Regulation of visfatin	Change from Baseline to 6 months	Decrease in visfatin levels
Regulation of oxLDL	Change from Baseline to 6 months	Decrease in oxLDL levels