Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD

Summary

NAFLD encompasses the entire spectrum of Fatty liver disease in individuals without significant alcohol consumption, ranging from fatty liver to steatohepatitis to cirrhosis. A high prevalence of NAFLD (62.5%) was observed in overweight/obese Indian adolescent (1). Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD (2). EASL guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss (3). Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation (4). There are various studies showing benefits of using other diets such as Low Fat Diet, Low Carbdohydrate diet, Low Fructose Diet, et. Though there are numerous studies in adults comparing Mediterranean diet vs Low Fat diet, date regarding the same in children are lacking. The aim of this study will be to compare the Effect of Indianized version of Mediterranean diet vs. Low Fat Diet on Hepatic Steatosis in Overweight children and adolescent with MASLD.

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease

Interventions

OTHER

Indianized version of Mediterranean Diet

Indo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Mediterranean diet, it will be specified to use Mustard oil, use of specific fruits like orange, apple, mosambi (avoid high glycemic fruits), use more of green leafy vegetables, Use of multigrain atta (Home made- 10 kg of multigrain atta will have - 8 kg of wheat + 500g each of Ragi+Bajra+ Jowar + Chana dal flour).

OTHER

Low Fat Diet

Low fat diet will have 50-60% carbohydrate, 20-30% fat (with \<10% saturated fat), and 20% protein. In the Low Fat Diet group, there will be only be restriction of total fat content to less than \<30%. They can use whichever household oil, consume any fruit or vegetables, any atta and no restriction on diary or non-vegetarian diet. Along with this, both groups will be given a list of do's and dont's. In the list of Do's , it will be mentioned to Eat plenty of vegetables, Fruits, Nuts, Whole grains, Screen time of less \<2 hrs /day (According to American academy of pediatrics) and Average hours of sleep in a day for age 8-18 = 8-9 hrs (According to American academy of sleep medicine). In the dont's list, it will be mentioned to avoid Sugar, Soda, Beverages, cold drinks, processed juices, processed food, junk foods, Maida, Ice cream, Creamy Desserts, Biscuit, chips and cake.

OTHER

Physical Activity

At least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking),

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-15

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• India

Study Locations