Clinical Trials Directory

Trials / Completed

CompletedNCT03203486

Response of NAFLD Patients to Mediterranean Diet

The Effectiveness of a Mediterranean Diet Intervention in NAFLD Clinical Course

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Harokopio University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMediterranean DietParticipants 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.

Timeline

Start date
2014-04-01
Primary completion
2014-07-01
Completion
2014-10-01
First posted
2017-06-29
Last updated
2017-06-29

Source: ClinicalTrials.gov record NCT03203486. Inclusion in this directory is not an endorsement.