Nonalcoholic Fatty Liver Disease
Conditions
Brief summary
The aim of this study was to evaluate the effects of mediterranean and low-fat diet on hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty liver disease. This randomized, single-blind controlled study conducted with obese adolescents aged 11-18 years who were admitted to Tepecik Training and Research Hospital Pediatric Gastroenterology Outpatient Clinic with the diagnosis of nonalcoholic fatty liver disease. Participants were randomly assigned to the Mediterranean diet or low-fat diet group.
Detailed description
This study was conducted to evaluate the effect of Mediterranean and low-fat diet on hepatic fat, inflammation and oxidative stress in obese adolescents with nonalcoholic fatty liver disease (NAFLD). The study, which was designed as a single blind randomized control, was completed with 44 obese adolescents diagnosed with NAFLD between the ages of 11-18. Adolescents were randomized to either a Mediterranean diet (n = 22) or a low-fat diet (control diet) (n = 22) for 12 weeks. At the beginning of the study and at the 12th week, adolescents' blood samples, physical activity and food consumption records were taken, anthropometric measurements and body composition analyzes were made, and antioxidant food consumption frequency and Mediterranean diet quality index questionnaire were applied to adolescents. In the controls performed at the 2th, 4th, 6th, 8th, and 10th weeks, the physical activity and food consumption records of the adolescents were repeated and anthropometric measurements and body composition analyzes were made again.
Interventions
OTHERMediterranean diet
Diet intervention:Mediterranean diet
OTHERControl diet: Low fat diet
Low fat diet
Sponsors
Izmir Katip Celebi University
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Being between the ages of 11-18 * Being obese (BMI ≥95.persentil) * Getting a diagnosis of Grade≥1 NAFLD
Exclusion criteria
* Existence of liver disease (wilson,hepatitis etc.) other than NAFLD * Drinking alcohol * Having a history of type 1 and type 2 diabetes * Using drugs that can cause steatosis * Using lipid-lowering drugs * Using weight loss medications * Having applied dietary therapy for any disease and weight loss * Existence of a chronic inflammatory disease * Existence of cancer * Thyroid dysfunction (hyperthyroid and hypothyroidism) * Existence of a history of hepatic virus infection * Having a history of parenteral nutrition * Being pregnant and breastfeeding * Receiving antibiotic treatment within 3 months prior to the study * Regularly consuming foods containing probiotic and prebiotic properties and / or using nutritional supplements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hepatic steatosis | Baseline and week 12 | Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients. |
| Changes in Inflammatory Parameters | Baseline and week 12 | Measurement of serum cytokines levels (C-reaktive protein (CRP), IL-10, IL-6, IL-8, IL-1 beta, TNF-alpha |
| Changes in oxidative stress markers | Baseline and week 12 | Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Paraoxonase Enzyme Activity (PON-1), Total Thiol, Native Thiol, Superoxide Dismutase (SOD), oxidized-LDL, Glutathione peroxidase,Malondialdehyde (MDA), Glutathione (GSH), non-esterified fatty acids (NEFA)) |
| Changes in glycemic profile | Baseline and week 12 | Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR |
| Changes in liver function tests | Baseline and week 12 | Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in BMI | baseline, week 2, week 4, week 6, week 8, week 10 and week 12 | weight and height will be measured to report BMI in kg/m2 |
| Changes in serum cholesterol levels | Baseline and week 12 | Measurement of total cholesterol, LDL, HDL cholesterol |
| Changes in some adipokines | Baseline and week 12 | Measurement of serum leptin and adiponectin |
| Changes in triglycerides | Baseline and week 12 | Measurement of serum triglyceride (mg/dl) |
| Changes in blood pressure | Baseline and week 12 | Measurement of systolic and diastolic blood pressure (mm Hg) |
| Changes in waist, hip and neck circumference | baseline, week 2, week 4, week 6, week 8, week 10 and week 12 | Measurement of waist circumference (cm) |
| Changes in Body Fat | baseline, week 2, week 4, week 6, week 8, week 10 and week 12 | Measurement of % body fat with BIA |
Countries
Turkey (Türkiye)
Outcome results
None listed