About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 8-18 years
BMI > 85th centile
CAP > 236
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Indianized version of Mediterranean Diet
Other interventionIndo 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 interventionLow 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 interventionAt least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking),
Treatment groups
Trial outcomes
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.
Secondary outcomes
To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.
To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.
To compare the changes in CAP value in PNPLA3 mutant children.
To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.
Sponsors and contacts
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