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

NCT ID: NCT06768216

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-12-31

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.

Detailed Description

Aim: To Study the effect of Indianized version of Mediterranean diet versus Low Fat diet on Non-Invasive markers of hepatic steatosis in children and adolescent with MASLD.

Primary objective: 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 objectives:

• 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.
• To compare the changes in following parameters in both study groups: Weight, BMI, HOMA IR and Lipid profile.
• To compare the adherence to IMD, with the help of Modified KIDMED score.
• Study design: Prospective, Randomized, Single center Open label study.
• Children and adolescent aged 8 to 18 years with CAP > 236dB/m will be enrolled in the study. Consent for dietary intervention will be taken. Baseline parameters analysed includes:

• Anthropometry :

• Weight, Height, BMI, Waist circumference
• Imaging:

• Ultrasonography abdomen, Fibroscan (LSM, CAP values)
• Biochemical parameters:

• ALT, AST, Lipid profile, HOMA IR
• Adiponectin & Cytokines: TNF alpha, IL6, IL-1β, and IL-17
• Liver Biopsy when indicated: ALT>80, LSM>8.6.
• Intervention:

Both the groups will have be given a handmade individualised (according to weight) specific diet to follow. Indo-Mediterranean diet will be given to one group and other group will have Calorie restricted diet. Indo Mediterranean diet will have Carbohydrates 40-45%, fats 30-35% and proteins 15-20%. Low fat diet will have 50-60% carbohydrate, 20-30% fat (with <10% saturated fat), and 20% protein. Calories will be calculated according to the age specified RDA from ICMR guidelines. In Indo-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). They will be advised to eat Dairy products in moderation and if non vegetarian diet (Fish, chicken, only twice a week). Dry fruits (Walnuts) and herbs (cinnamon, garlic, basil, and pepper) will be an important part of the diet. 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, at least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking), 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.

• Monitoring and assessment: All Parameters will be re-assessed at 180 days (except liver biopsy). Both groups will be explained to maintain a food diary mentioning cheat days (Food other than the diet given), screen time (<2hrs/day), Exercise (45-60 mins/day, parameters will be checked by pedometer app) and average hours of sleep (8-9hrs/day). Food diary will be checked once in two weeks on phone calls or virtual OPD. Once weekly phone calls (30 mins) will be checked to see the adherence and to motivate the child. They will be required to follow up in OPD once in a month. Adherence to Indo Mediterranean diet will be assessed by Modified KIDMED score.

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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),

Group Type: ACTIVE_COMPARATOR

Indianized version of Mediterranean Diet

Intervention Type: 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).

Physical Activity

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Low Fat Diet

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Physical Activity

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr Ashray S Patel, MD

Role: CONTACT

patel1995ash@gmail.com

01146300000

Prof. Seema Alam, MD

Role: CONTACT

seema_alam@hotmail.com

01146300000

Facility Contacts

Dr Ashray S Patel, MD

Role: primary

patel1995ash@gmail.com

01146300000

Other Identifiers

ILBS-MASDL-01

Identifier Type: -

Identifier Source: org_study_id