Response of NAFLD Patients to Mediterranean Diet

NAFLD Clinical Trial

Official title:

The Effectiveness of a Mediterranean Diet Intervention in NAFLD Clinical Course

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203486
• Other study ID #: 09-S??-12-890
• Status: Completed
• Phase: N/A
• First received: June 26, 2017
• Last updated: June 27, 2017
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: June 2017
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Steatosis of Liver

Intervention

Other:
• Mediterranean Diet
Participants were instructed to include vegetables, whole grains and fruits in their diet and increase fish, legumes and raw nut intake. Emphasis was given to extra virgin olive oil as the main added fat in meals. Particular attention was drained to decrease fermented dairy and poultry, with small amounts of red meat and homemade sweets. All participants were given meal plans in which the distribution of nutrients in relation to total caloric value was as follows: 40% of total energy as fat (50% as MUFAs), 20% as protein, 40% as carbohydrate, 300mg/d as dietary cholesterol and 20-30g fiber/d.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Harokopio University	Greek Secretariat for Research and Technology, National and Kapodistrian University of Athens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regulation of hepatic steatosis	A decrease in liver fat	Change from Baseline to 6 months
Secondary	Adherence to MedDiet	Increase in MedDietScore	Change from Baseline to 6 months
Secondary	Regulation of visfatin	Decrease in visfatin levels	Change from Baseline to 6 months
Secondary	Regulation of oxLDL	Decrease in oxLDL levels	Change from Baseline to 6 months
Secondary	Association of single nucleotide polymorphisms to response to dietary treatment	Decrease in visfatin in carriers of the risk allele	Change from Baseline to 6 months