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

NCT06768216 | Recruiting

• 1 other identifier: ILBS-MASDL-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.

  180 days

• To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.

  180 days

• To compare the changes in CAP value in PNPLA3 mutant children.

  180 days

• To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.

  180 days

• To compare the changes in following parameters in both study groups: Weight.

  180 days

Study Arms (2)

Indianized version of Mediterranean Diet+Physical Activity

ACTIVE COMPARATOR

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),

Other: Indianized version of Mediterranean Diet; Other: Physical Activity

Low Fat Diet + Physical Activity

EXPERIMENTAL

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.

Other: Low Fat Diet; Other: Physical Activity

Interventions

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.

Low Fat Diet + Physical Activity

Physical Activity OTHER

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

Indianized version of Mediterranean Diet+Physical Activity; Low Fat Diet + Physical Activity

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).

Indianized version of Mediterranean Diet+Physical Activity

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 8-18 years
• BMI \> 85th centile
• CAP \> 236

You may not qualify if:

• \- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Interventions

Diet, Fat-Restricted; Exercise

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dr Ashray S Patel, MD

CONTACT

01146300000; patel1995ash@gmail.com

Prof. Seema Alam, MD

CONTACT

01146300000; seema_alam@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 10, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

IN (1)