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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04845373
Other study ID # 47/2020-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2020
Est. completion date November 29, 2020

Study information

Verified date April 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 29, 2020
Est. primary completion date November 29, 2020
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Mediterranean diet
Diet intervention:Mediterranean diet
Control diet: Low fat diet
Low fat diet

Locations

Country Name City State
Turkey Izmir Tepecik Training and Research Hospital Izmir

Sponsors (2)

Lead Sponsor Collaborator
Gazi University Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in hepatic steatosis Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients. Baseline and week 12
Primary 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
Primary 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
Primary Changes in glycemic profile Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR Baseline and week 12
Primary Changes in liver function tests Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP) Baseline and week 12
Secondary Changes in serum cholesterol levels Measurement of total cholesterol, LDL, HDL cholesterol Baseline and week 12
Secondary Changes in triglycerides Measurement of serum triglyceride (mg/dl) Baseline and week 12
Secondary Changes in blood pressure Measurement of systolic and diastolic blood pressure (mm Hg) Baseline and week 12
Secondary 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
Secondary Changes in Body Fat Measurement of % body fat with BIA baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Secondary 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
Secondary Changes in some adipokines Measurement of serum leptin and adiponectin Baseline and week 12
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