Effect of Indo-Mediterranean Diet on Hepatic Steatosis and Fibrosis in NAFLD Children

NCT05073588 | Completed DMC

• 1 other identifier: ILBS-NAFLD-01
• Study Type: interventional
• Target: 39
• 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. Lifestyle modification consisting of diet, exercise and weight loss has been advocated to treat patients with NAFLD. European association for study of liver (EASL) guidelines recommends that the macronutrient in the diet should be adjusted according to the Mediterranean diet for weight loss. Mediterranean diet helps to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative stress and by increasing fatty acids beta oxidation.There are numerous studies in adults showing benefit of Mediterranean diet in comparison with other diet in NAFLD, but data on children is very limited. There are no studies in pediatrics showing the benefit of diet intervention in Indian NAFLD children. The aim of this study will be to compare the effect of Indo-Mediterranean diet and calorie restricted on hepatic steatosis and fibrosis in Overweight Indian children and adolescent with Biopsy proven NAFLD.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD; Indo-Mediterranean diet; Calorie restricted diet

Outcome Measures

Primary Outcomes (1)

• The Primary outcome measure will be a composite end point defined by decrease in Controlled Attenuation Parameter (CAP) and Alanine Aminotransferase (ALT) values by 10% from baseline and decrease in Pediatric NAFLD Fibrosis Index score <3

  Decrease in CAP and ALT values by 10% from baseline and decrease in Pediatric NAFLD Fibrosis Index score \<3

  180 days

Secondary Outcomes (2)

• Weight (Time frame : Change in Weight of atleast 7% from baseline at 180 days)

  180 days

• Lipid Profile (Time frame : Change in Cholesterol, triglycerides of atleast 10% from baseline at 180 days)

  180 days

Study Arms (2)

Indo Mediterranean diet

ACTIVE COMPARATOR

Indian version of Mediterranean diet will be given to NAFLD children

Other: Indo Mediterranean diet

Calorie restricted Diet

ACTIVE COMPARATOR

Diet restricted in calories will be given to NAFLD children

Other: Calorie restricted diet

Interventions

Indo Mediterranean diet OTHER

Mediterranean diet has been shown to be effective in NAFLD adult patients. In India, it is very difficult to follow Mediterranean diet, so one group will be given Indianized version of mediterranean diet.

Indo Mediterranean diet

Calorie restricted diet OTHER

One group will be given diet restricted in calories, which most of the patients follow to lose weight

Calorie restricted Diet

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8-18 years
• BMI \> 85th centile
• Ultrasonography abdomen s/o Fatty Liver
• Biopsy proven NAFLD

You may not qualify if:

• Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease
• Liver Biopsy not done
• Refused Consent

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and biliary sciences

Delhi, 110070, India

Location

Related Publications (1)

• Deshmukh A, Sood V, Lal BB, Khanna R, Alam S, Sarin SK. Effect of Indo-Mediterranean diet versus calorie-restricted diet in children with non-alcoholic fatty liver disease: A pilot randomized control trial. Pediatr Obes. 2024 Nov;19(11):e13163. doi: 10.1111/ijpo.13163. Epub 2024 Sep 2.

  PMID: 39223952 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Aniket Deshmukh, DM

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, Randomized, Single centre Open label study

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 11, 2021
• Study Start: August 16, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: October 16, 2023

Record last verified: 2022-09

Locations

IN (1)