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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-05

Study Completion Date

2020-11-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nonalcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mediterrenean diet

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.

Group Type EXPERIMENTAL

Mediterranean diet

Intervention Type OTHER

Diet intervention:Mediterranean diet

Low fat diet

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.

Group Type ACTIVE_COMPARATOR

Control diet: Low fat diet

Intervention Type OTHER

Low fat diet

Interventions

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Mediterranean diet

Diet intervention:Mediterranean diet

Intervention Type OTHER

Control diet: Low fat diet

Low fat diet

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No