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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Other: Indianized version of Mediterranean Diet; Other: Physical Activity; Other: Low Fat Diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Ashray S Patel, MD; Phone Number: 01146300000; Email: patel1995ash@gmail.com
• Study Contact Backup: Name: Prof. Seema Alam, MD; Phone Number: 01146300000; Email: seema_alam@hotmail.com

Study Locations

• India
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Ashray S Patel, MD; Phone Number: 01146300000; Email: patel1995ash@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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),	Other: 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).; Other: Physical Activity; 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.	Other: Physical Activity; At least 45- 60 mins of exercise (peer group activity - cycling, football, brisk walking),; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
To compare the changes in following parameters in both study groups: BMI.	180 days
To compare the changes in following parameters in both study groups: HOMA IR .	180 days
To compare the changes in following parameters in both study groups: Lipid profile.	180 days
To compare the adherence to IMD, with the help of Modified KIDMED score.	180 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Overweight; Liver Diseases; Fatty Liver; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Exercise; Diet, Fat-Restricted
• Other Study ID Numbers: ILBS-MASDL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No