Effect of Mediterranean Diet in Obese Adolescents With Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Mediterranean Diet and Low Fat Diet on Hepatic Fat, Inflammation and Oxidative Stress in Obese Adolescents With Nonalcoholic Fatty Liver Disease

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: Mediterranean diet
* Other: Control diet: Low fat diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterrenean diet<br>Mediterranean diet:Target macronutrient energy contributions were 40% from carbohydrate, 35%-40% from fat (with <10% of energy as saturated fat), and 20% of energy as protein.Participant in this group were trained to consume fish, legumes at least 2-3 times a week, walnuts and olive oil every day in accordance with the Mediterranean diet model. | Other: Mediterranean diet<br>* Diet intervention:Mediterranean diet<br>|
| Active Comparator: Low fat diet<br>Low fat diet:Target macronutrient energy contributions for the low fat diet diet were 50-60% from carbohydrate, <30% from fat (with <10% of energy as saturated fat), and 20% from protein.Participants in this group were especially recommended to consume low-fat foods. | Other: Control diet: Low fat diet<br>* Low fat diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hepatic steatosis | Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients. | Baseline and week 12 | 
| Changes in Inflammatory Parameters | Measurement of serum cytokines levels (C-reaktive protein (CRP), IL-10, IL-6, IL-8, IL-1 beta, TNF-alpha | Baseline and week 12 | 
| Changes in oxidative stress markers | 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)) | Baseline and week 12 | 
| Changes in glycemic profile | Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR | Baseline and week 12 | 
| Changes in liver function tests | Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP) | Baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum cholesterol levels | Measurement of total cholesterol, LDL, HDL cholesterol | Baseline and week 12 | 
| Changes in triglycerides | Measurement of serum triglyceride (mg/dl) | Baseline and week 12 | 
| Changes in blood pressure | Measurement of systolic and diastolic blood pressure (mm Hg) | Baseline and week 12 | 
| Changes in waist, hip and neck circumference | Measurement of waist circumference (cm) | baseline, week 2, week 4, week 6, week 8, week 10 and week 12 | 
| Changes in Body Fat | Measurement of % body fat with BIA | baseline, week 2, week 4, week 6, week 8, week 10 and week 12 | 
| Changes in BMI | weight and height will be measured to report BMI in kg/m2 | baseline, week 2, week 4, week 6, week 8, week 10 and week 12 | 
| Changes in some adipokines | Measurement of serum leptin and adiponectin | Baseline and week 12 |