Non-Alcoholic Fatty Liver Disease Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• Age: 8-18 years

• BMI \> 85th centile

• CAP \> 236

Locations
Other Locations
India
Institute of Liver & Biliary Sciences
RECRUITING
New Delhi
Contact Information
Primary
Dr Ashray S Patel, MD
patel1995ash@gmail.com
01146300000
Backup
Prof. Seema Alam, MD
seema_alam@hotmail.com
01146300000
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 134
Treatments
Active_comparator: Indianized version of Mediterranean Diet+Physical Activity
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). At least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking),
Experimental: Low Fat Diet + Physical Activity
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.
Related Therapeutic Areas
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov