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OpenTrials
Completed

NCT Number: NCT04845373

Effect of Mediterranean Diet 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.

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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İzmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet

Other

Diet intervention:Mediterranean diet

Control diet: Low fat diet

Other

Low fat diet

Primary outcomes

  1. Changes in hepatic steatosis

    Time frame: Baseline and week 12

    Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.

  2. Changes in Inflammatory Parameters

    Time frame: Baseline and week 12

    Measurement of serum cytokines levels (C-reaktive protein (CRP), IL-10, IL-6, IL-8, IL-1 beta, TNF-alpha

  3. Changes in oxidative stress markers

    Time frame: 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))

  4. Changes in glycemic profile

    Time frame: Baseline and week 12

    Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR

  5. Changes in liver function tests

    Time frame: Baseline and week 12

    Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)

Secondary outcomes

  1. Changes in serum cholesterol levels

    Time frame: Baseline and week 12

    Measurement of total cholesterol, LDL, HDL cholesterol

  2. Changes in triglycerides

    Time frame: Baseline and week 12

    Measurement of serum triglyceride (mg/dl)

  3. Changes in blood pressure

    Time frame: Baseline and week 12

    Measurement of systolic and diastolic blood pressure (mm Hg)

  4. Changes in waist, hip and neck circumference

    Time frame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12

    Measurement of waist circumference (cm)

  5. Changes in Body Fat

    Time frame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12

    Measurement of % body fat with BIA

  6. Changes in BMI

    Time frame: 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

  7. Changes in some adipokines

    Time frame: Baseline and week 12

    Measurement of serum leptin and adiponectin

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

  • Izmir Katip Celebi University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2021
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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