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

Not Applicable

Completed

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Other: Mediterranean diet

• Registration Number: NCT04845373
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2020-01-05
• Study First Submitted: 2020-11-13
• Primary Completion: 2020-11-29
• Study Completion: 2020-11-29
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-13
• Last Update Submitted: 2021-04-13
• Study First Posted: 2021-04-15
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterrenean diet	Mediterranean diet	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.

Primary Outcome Measures

Name	Time	Method
Changes in glycemic profile	Baseline and week 12	Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR
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 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 hepatic steatosis	Baseline and week 12	Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.
Changes in liver function tests	Baseline and week 12	Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)

Secondary Outcome Measures

Name	Time	Method
Changes in Body Fat	baseline, week 2, week 4, week 6, week 8, week 10 and week 12	Measurement of % body fat with BIA
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 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 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 blood pressure	Baseline and week 12	Measurement of systolic and diastolic blood pressure (mm Hg)

Trial Locations

Locations (1)

İzmir Tepecik Training and Research Hospital; 🇹🇷 İzmir, Turkey