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

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mediterranean diet
Control diet: Low fat diet
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • İzmir Tepecik Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterrenean diet

Low fat diet

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes in hepatic steatosis
Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.
Changes in Inflammatory Parameters
Measurement of serum cytokines levels (C-reaktive protein (CRP), IL-10, IL-6, IL-8, IL-1 beta, TNF-alpha
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))
Changes in glycemic profile
Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR
Changes in liver function tests
Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)

Secondary Outcome Measures

Changes in serum cholesterol levels
Measurement of total cholesterol, LDL, HDL cholesterol
Changes in triglycerides
Measurement of serum triglyceride (mg/dl)
Changes in blood pressure
Measurement of systolic and diastolic blood pressure (mm Hg)
Changes in waist, hip and neck circumference
Measurement of waist circumference (cm)
Changes in Body Fat
Measurement of % body fat with BIA
Changes in BMI
weight and height will be measured to report BMI in kg/m2
Changes in some adipokines
Measurement of serum leptin and adiponectin

Full Information

First Posted
November 13, 2020
Last Updated
April 13, 2021
Sponsor
Gazi University
Collaborators
Izmir Katip Celebi University
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1. Study Identification

Unique Protocol Identification Number
NCT04845373
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
November 29, 2020 (Actual)
Study Completion Date
November 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Izmir Katip Celebi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterrenean diet
Arm Type
Experimental
Arm 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.
Arm Title
Low fat diet
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Mediterranean diet
Intervention Description
Diet intervention:Mediterranean diet
Intervention Type
Other
Intervention Name(s)
Control diet: Low fat diet
Intervention Description
Low fat diet
Primary Outcome Measure Information:
Title
Changes in hepatic steatosis
Description
Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.
Time Frame
Baseline and week 12
Title
Changes in Inflammatory Parameters
Description
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
Title
Changes in oxidative stress markers
Description
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
Title
Changes in glycemic profile
Description
Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR
Time Frame
Baseline and week 12
Title
Changes in liver function tests
Description
Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Changes in serum cholesterol levels
Description
Measurement of total cholesterol, LDL, HDL cholesterol
Time Frame
Baseline and week 12
Title
Changes in triglycerides
Description
Measurement of serum triglyceride (mg/dl)
Time Frame
Baseline and week 12
Title
Changes in blood pressure
Description
Measurement of systolic and diastolic blood pressure (mm Hg)
Time Frame
Baseline and week 12
Title
Changes in waist, hip and neck circumference
Description
Measurement of waist circumference (cm)
Time Frame
baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Title
Changes in Body Fat
Description
Measurement of % body fat with BIA
Time Frame
baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Title
Changes in BMI
Description
weight and height will be measured to report BMI in kg/m2
Time Frame
baseline, week 2, week 4, week 6, week 8, week 10 and week 12
Title
Changes in some adipokines
Description
Measurement of serum leptin and adiponectin
Time Frame
Baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
İzmir Tepecik Training and Research Hospital
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34881510
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.
Results Reference
derived

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

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