NAFLD, Steatosis of Liver
Conditions
Keywords
NAFLD, no fibrosis, Mediterranean diet, STAT3, GCKR, visfatin, oxidized LDL, fasting glucose, inflammation
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.
Interventions
OTHERMediterranean 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.
Sponsors
National and Kapodistrian University of Athens
Greek Secretariat for Research and Technology
Harokopio University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
non-randomised, open-label study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regulation of hepatic steatosis | Change from Baseline to 6 months | A decrease in liver fat |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to MedDiet | Change from Baseline to 6 months | Increase in MedDietScore |
| 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 |
| 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 |
Outcome results
None listed