Mediterranean Diet Treatment for NAFLD

NCT04415112 | Completed

• 1 other identifier: 2017-234
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Mediterranean Diet

Keywords

Non Alcoholic Fatty Liver Disease; Mediterranean Diet; Low Fat Diet; Children

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (3)

• Evaluate the effects of the both diets in insulin resistance

  12 weeks

• Evaluate the effects of the both diets in capillary blood glucose

  12 weeks

• Evaluate the effects of the both diets in fasting insulin levels

  12 weeks

Study Arms (2)

Mediterranean Diet

ACTIVE COMPARATOR

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.

Behavioral: Mediterranean Diet

Low Fat Diet

ACTIVE COMPARATOR

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

Behavioral: Low Fat Diet

Interventions

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.

Mediterranean Diet

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.

Low Fat Diet

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Ulas Emre Akbulut

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29729189 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet, Mediterranean; Diet, Fat-Restricted

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 Officials

• Ulas E Akbulut

  Antalya Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study design was single blind and the participants did not know what diet they had taken.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: January 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)