İzmir Tepecik Training and Research Hospital
Izmir, Turkey (Türkiye)
NCT Number: NCT04845373
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.
Looking for future studies?
Notify Me11 year–18 year
All sexes
Interventional
Not applicable
Izmir, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diet intervention:Mediterranean diet
Low fat diet
Time frame: Baseline and week 12
Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.
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
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))
Time frame: Baseline and week 12
Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR
Time frame: Baseline and week 12
Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)
Time frame: Baseline and week 12
Measurement of total cholesterol, LDL, HDL cholesterol
Time frame: Baseline and week 12
Measurement of serum triglyceride (mg/dl)
Time frame: Baseline and week 12
Measurement of systolic and diastolic blood pressure (mm Hg)
Time frame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Measurement of waist circumference (cm)
Time frame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Measurement of % body fat with BIA
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
Time frame: Baseline and week 12
Measurement of serum leptin and adiponectin
Gazi University
Other
The Effect of Mediterranean Diet and Low Fat Diet on Hepatic Fat, Inflammation and Oxidative Stress in Obese Adolescents With Nonalcoholic Fatty Liver Disease
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.
Published trials that share one or more normalized conditions with this study.
NCT06482112
Digestive System Diseases, Fatty Liver
Chandler, Arizona, United States
View Trial DetailsNCT04801849
Digestive System Diseases, Fatty Liver
La Jolla, California, United States
View Trial DetailsNCT05877547
Digestive System Diseases, Fatty Liver
Chandler, Arizona, United States
View Trial DetailsNCT05560607
Digestive System Diseases, Fatty Liver
San Antonio, Texas, United States
View Trial Details