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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845373
• Other study ID #: 47/2020-05
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

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