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Mediterranean Diet Treatment for NAFLD

Primary Purpose

Mediterranean Diet

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mediterranean Diet
Low Fat Diet
Sponsored by
Antalya Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mediterranean Diet focused on measuring Non Alcoholic Fatty Liver Disease, Mediterranean Diet, Low Fat Diet, Children

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of NAFLD
  • Body mass index z-score >85th percentile

Exclusion Criteria:

  • Secondary causes of NAFLD (eg. medication induced)
  • Use of weight loss medications
  • Diabetes Mellitus
  • Other causes of fatty liver disease (eg. Wilson disease, alpha-1 antitrypsin deficiency, auto-immune hepatitis, and viral hepatitis)

Sites / Locations

  • Ulas Emre Akbulut

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mediterranean Diet

Low Fat Diet

Arm Description

The MD diet is rich in plant based foods including vegetables, whole cereal and fruit with the main added fat being extra virgin olive oil. In addition, the diet emphasises, while consumption of legumes, nuts and fish is high, consumption of red meat and home-made desserts is low, and consumption of fermented milk and poultry is moderate. The MD diet had a target macronutrient composition of 35-40% fat (with <10% of energy as saturated fat), 40-44% carbohydrate and 20% protein.

The Low Fat diet had a target macronutrient composition of 55% of energy from carbohydrate, 20-25% from fat (with <10% of energy as saturated fat) and 20-25% from protein. Nutrition education focused on choosing foods containing ≤3 grams of fat/serving, limiting added fats, and using low-fat meal preparation strategies. Parents were instructed to offer their children ample amounts of grains, vegetables, fruits, lean meats, low-fat dairy products and limit high-fat foods

Outcomes

Primary Outcome Measures

Non-alcoholic Fatty Liver Disease Ultrasonography Score
A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used. Degrees of steatosis range from 0 (no steatosis) to 3 (severe steatosis), according to Hamaguchi score, which used a 6-point scoring system based on liver brightness.

Secondary Outcome Measures

Evaluate the effects of the both diets in insulin resistance
Changes in Homeostatic Model Assessment of Insulin Resistance from baseline to 12-week post Mediterranean diet and low fat diet intervention
Evaluate the effects of the both diets in capillary blood glucose
Changes in fasting capillary blood glucose (mg/dL) from baseline to 12-week post Mediterranean diet and low fat diet intervention
Evaluate the effects of the both diets in fasting insulin levels
Changes in fasting insulin (μU/mL) levels from baseline to 12-week post Mediterranean diet and low fat diet intervention

Full Information

First Posted
May 27, 2020
Last Updated
May 30, 2020
Sponsor
Antalya Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04415112
Brief Title
Mediterranean Diet Treatment for NAFLD
Official Title
Effectiveness of a Mediterranean Diet to Treat Non-Alcoholic Fatty Liver Disease in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
Treatment for Nonalcoholic Fatty Liver Disease (NAFLD) is through lifestyle modification consisting of caloric restriction and exercise, with an emphasis on weight loss. Unfortunately, the success and longevity of lifestyle changes that focus on weight loss, are poor in children. The dietary recommendation of calorie restriction alone may not be optimal in a pediatric population for multiple reasons including changes in hormonal milieu, growth velocity, and decreased bone mineral density that occur with significant weight loss. Mediterranean Diet (MD) is based on the high intake of extra virgin olive oil, vegetables, fruits, cereals, nuts and legumes; moderate intakes of fish and other meats, dairy products and red wine and low intakes of eggs and sweets. So, it provides a large amount of monounsaturated fatty acids, polyunsaturated fatty acids, vegetable proteins, fibre and antioxidants; and low amounts of sugar, cholesterol and saturated fats. It offers a lot of choice in food selection, and well tolerated, and many people can adhere to it over the long term. The investigators aimed to evaluate the effects of a MD vs. low fat diet on changes in hepatic steatosis, aminotransferases, and anthropometric measurements among obese children with NAFLD
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is a disease caused by abnormal lipid accumulation in the liver without alcohol intake or other organic causes. NAFLD covers a range of liver diseases ranging from simple oil infiltration to non-alcoholic steatohepatitis (NASH), fibrosis and cirrhosis. The most important risk factor in the development of NAFLD is insulin resistance due to obesity. Insulin resistance increases hepatic steatosis and accumulation of hepatic fatty acids by increasing peripheral lipolysis and the entry of fatty acids into the liver. In parallel with the increased prevalence of childhood obesity, the occurrence of NAFLD is increasing among children. The risk that the NAFLD can turn into chronic liver disease increases the importance of the disease even more when children become adults Mediterranean Diet (MD) has gained popularity in scientific literature because it is one of the healthiest diets in the world.This diet is based on the high intake of extra virgin olive oil, vegetables, fruits, cereals, nuts and legumes; moderate intakes of fish and other meats, dairy products and red wine and low intakes of eggs and sweets. So, it provides a large amount of monounsaturated fatty acids, polyunsaturated fatty acids, vegetable proteins, fibre and antioxidants; and low amounts of sugar, cholesterol and saturated fats. MD is characterized as low-carbohydrate (40% of calories) and in contrast to low-fat diets, the MD includes fat as 40% of the diet. It offers a lot of choice in food selection, and well tolerated, and many people can adhere to it over the long term. There are a limited number of studies investigating the effectiveness of the MD in NAFLD treatment in different countries. However, there are no studies in the treatment of children with NAFLD in Turkey. The primary aims to this study is to evaluate the effects of a MD vs. low fat diet on changes in hepatic steatosis, aminotransferases, and anthropometric measurements among obese children with NAFLD in Turkey. The secondary aim to this study is to evaluate the effects of the both diets in insulin resistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediterranean Diet
Keywords
Non Alcoholic Fatty Liver Disease, Mediterranean Diet, Low Fat Diet, Children

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design was a single-blinded randomized, parallel assignment clinical trial of children with NAFLD was conducted. Participants were randomized in a 1:1 fashion to either 12-weeks of a Mediterranean diet or a low fat diet.
Masking
Participant
Masking Description
The study design was single blind and the participants did not know what diet they had taken.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Active Comparator
Arm Description
The MD diet is rich in plant based foods including vegetables, whole cereal and fruit with the main added fat being extra virgin olive oil. In addition, the diet emphasises, while consumption of legumes, nuts and fish is high, consumption of red meat and home-made desserts is low, and consumption of fermented milk and poultry is moderate. The MD diet had a target macronutrient composition of 35-40% fat (with <10% of energy as saturated fat), 40-44% carbohydrate and 20% protein.
Arm Title
Low Fat Diet
Arm Type
Active Comparator
Arm Description
The Low Fat diet had a target macronutrient composition of 55% of energy from carbohydrate, 20-25% from fat (with <10% of energy as saturated fat) and 20-25% from protein. Nutrition education focused on choosing foods containing ≤3 grams of fat/serving, limiting added fats, and using low-fat meal preparation strategies. Parents were instructed to offer their children ample amounts of grains, vegetables, fruits, lean meats, low-fat dairy products and limit high-fat foods
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean Diet
Intervention Description
A list of foods high consumption of vegetables, fruits, non-refined cereals, legumes and potatoes, moderate consumption of fish and poultry and low consumption of full fat dairies, red meat and its products and homemade sweets.
Intervention Type
Behavioral
Intervention Name(s)
Low Fat Diet
Intervention Description
These children are forbidden to eat high-fat foods such as fried foods, butter, cream cheese, while foods such as fruits, vegetables (starchy and non-starch), cereals, poultry, lean meat and low-fat dairy products are allowed.
Primary Outcome Measure Information:
Title
Non-alcoholic Fatty Liver Disease Ultrasonography Score
Description
A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used. Degrees of steatosis range from 0 (no steatosis) to 3 (severe steatosis), according to Hamaguchi score, which used a 6-point scoring system based on liver brightness.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Evaluate the effects of the both diets in insulin resistance
Description
Changes in Homeostatic Model Assessment of Insulin Resistance from baseline to 12-week post Mediterranean diet and low fat diet intervention
Time Frame
12 weeks
Title
Evaluate the effects of the both diets in capillary blood glucose
Description
Changes in fasting capillary blood glucose (mg/dL) from baseline to 12-week post Mediterranean diet and low fat diet intervention
Time Frame
12 weeks
Title
Evaluate the effects of the both diets in fasting insulin levels
Description
Changes in fasting insulin (μU/mL) levels from baseline to 12-week post Mediterranean diet and low fat diet intervention
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of NAFLD Body mass index z-score >85th percentile Exclusion Criteria: Secondary causes of NAFLD (eg. medication induced) Use of weight loss medications Diabetes Mellitus Other causes of fatty liver disease (eg. Wilson disease, alpha-1 antitrypsin deficiency, auto-immune hepatitis, and viral hepatitis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulas E Akbulut
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ulas Emre Akbulut
City
Antalya
ZIP/Postal Code
07100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29729189
Citation
Properzi C, O'Sullivan TA, Sherriff JL, Ching HL, Jeffrey GP, Buckley RF, Tibballs J, MacQuillan GC, Garas G, Adams LA. Ad Libitum Mediterranean and Low-Fat Diets Both Significantly Reduce Hepatic Steatosis: A Randomized Controlled Trial. Hepatology. 2018 Nov;68(5):1741-1754. doi: 10.1002/hep.30076. Epub 2018 Oct 14.
Results Reference
result

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Mediterranean Diet Treatment for NAFLD

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