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

NCT04845373 | Completed DMC

• 1 other identifier: 47/2020-05
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (5)

• Changes in hepatic steatosis

  Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.

  Baseline and week 12

• 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

• 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

• Changes in glycemic profile

  Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR

  Baseline and week 12

• Changes in liver function tests

  Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)

  Baseline and week 12

Secondary Outcomes (7)

• Changes in serum cholesterol levels

  Baseline and week 12

• Changes in triglycerides

  Baseline and week 12

• Changes in blood pressure

  Baseline and week 12

• Changes in waist, hip and neck circumference

  baseline, week 2, week 4, week 6, week 8, week 10 and week 12

• Changes in Body Fat

  baseline, week 2, week 4, week 6, week 8, week 10 and week 12

Study Arms (2)

Mediterrenean diet

EXPERIMENTAL

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.

Other: Mediterranean diet

Low fat diet

ACTIVE COMPARATOR

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.

Other: Control diet: Low fat diet

Interventions

Mediterranean diet OTHER

Diet intervention:Mediterranean diet

Mediterrenean diet

Control diet: Low fat diet OTHER

Low fat diet

Low fat diet

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being between the ages of 11-18
• Being obese (BMI ≥95.persentil)
• Getting a diagnosis of Grade≥1 NAFLD

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead
• Izmir Katip Celebi University: collaborator

Study Sites (1)

İzmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34881510 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: April 15, 2021
• Study Start: January 5, 2020
• Primary Completion: November 29, 2020
• Study Completion: November 29, 2020
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)