Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06768216

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionMetabolic Dysfunction-Associated Steatotic Liver Disease

Full registry criteria

Inclusion Criteria: 1. Age: 8-18 years 2. BMI \> 85th centile 3. CAP \> 236 Exclusion Criteria: \- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.

Treatments and study arms

Indianized version of Mediterranean Diet

Other

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).

Low Fat Diet

Other

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.

Physical Activity

Other

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

Primary outcomes

To compare the proportions of patients achieving normal CAP values (<236db/m) after 180 days of IMD versus LFD in children and adolescent with MASLD.180 days

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Institute of Liver & Biliary Sciences🇮🇳 New Delhi, National Capital Territory of Delhi, India

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Dr Ashray S Patel, MDContact

Email · Call 01146300000