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

Gazi University

Status: Completed

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Other: Control diet: Low fat diet; Other: Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04845373

47/2020-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Mediterrenean diet

Experimental group

Description:

Mediterranean diet:Target macronutrient energy contributions were 40% from carbohydrate, 35%-40% from fat (with \<10% of energy as saturated fat), and 20% of energy as protein.Participant in this group were trained to consume fish, legumes at least 2-3 times a week, walnuts and olive oil every day in accordance with the Mediterranean diet model.

Treatment:

Other: Mediterranean diet

Low fat diet

Active Comparator group

Description:

Low fat diet:Target macronutrient energy contributions for the low fat diet diet were 50-60% from carbohydrate, \<30% from fat (with \<10% of energy as saturated fat), and 20% from protein.Participants in this group were especially recommended to consume low-fat foods.

Treatment:

Other: Control diet: Low fat diet