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

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

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.

Study Overview

• Status: Completed
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Mediterranean diet; Other: Control diet: Low fat diet

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Izmir Tepecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterrenean 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.	Other: Mediterranean diet; Diet intervention:Mediterranean diet
Active Comparator: Low fat diet; 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; Low fat diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gazi University
• Collaborators: Izmir Katip Celebi University

Publications and helpful links

General Publications

• Yurtdas G, Akbulut G, Baran M, Yilmaz C. The effects of Mediterranean diet on hepatic steatosis, oxidative stress, and inflammation in adolescents with non-alcoholic fatty liver disease: A randomized controlled trial. Pediatr Obes. 2022 Apr;17(4):e12872. doi: 10.1111/ijpo.12872. Epub 2021 Dec 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Actual): November 29, 2020
• Study Completion (Actual): November 29, 2020

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 47/2020-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No