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NCT Number: NCT04415112

Mediterranean Diet Treatment for NAFLD

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

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Key information

Conditions

Mediterranean Diet Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulas Emre Akbulut

Antalya, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mediterranean Diet

Behavioral

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.

Low Fat Diet

Behavioral

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 outcomes

  1. Non-alcoholic Fatty Liver Disease Ultrasonography Score

    Time frame: 12 weeks

    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 outcomes

  1. Evaluate the effects of the both diets in insulin resistance

    Time frame: 12 weeks

    Changes in Homeostatic Model Assessment of Insulin Resistance from baseline to 12-week post Mediterranean diet and low fat diet intervention

  2. Evaluate the effects of the both diets in capillary blood glucose

    Time frame: 12 weeks

    Changes in fasting capillary blood glucose (mg/dL) from baseline to 12-week post Mediterranean diet and low fat diet intervention

  3. Evaluate the effects of the both diets in fasting insulin levels

    Time frame: 12 weeks

    Changes in fasting insulin (μU/mL) levels from baseline to 12-week post Mediterranean diet and low fat diet intervention

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Effectiveness of a Mediterranean Diet to Treat Non-Alcoholic Fatty Liver Disease in Children

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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