Clinical trial NCT04845373: Effect of Mediterranean Diet in Obese Adolescents With Nonalcoholic Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
First posted: 2021-04-15
Enrollment: 44
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in hepatic steatosis
timeFrame: Baseline and week 12
measure: Changes in Inflammatory Parameters
timeFrame: Baseline and week 12
measure: Changes in oxidative stress markers
timeFrame: Baseline and week 12
measure: Changes in glycemic profile
timeFrame: Baseline and week 12
measure: Changes in liver function tests
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Changes in serum cholesterol levels
timeFrame: Baseline and week 12
measure: Changes in triglycerides
timeFrame: Baseline and week 12
measure: Changes in blood pressure
timeFrame: Baseline and week 12
measure: Changes in waist, hip and neck circumference
timeFrame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
measure: Changes in Body Fat
timeFrame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
measure: Changes in BMI
timeFrame: baseline, week 2, week 4, week 6, week 8, week 10 and week 12
measure: Changes in some adipokines
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Tepecik Training and Research Hospital
Study officials:
References:
citation: 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.