Clinical trial NCT06768216: Effect of Indianized Version of Mediterranean Diet vs. Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescent With MASLD
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 134
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 180 days
Secondary outcomes:
measure: To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.
timeFrame: 180 days
measure: To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.
timeFrame: 180 days
measure: To compare the changes in CAP value in PNPLA3 mutant children.
timeFrame: 180 days
measure: To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.
timeFrame: 180 days
measure: To compare the changes in following parameters in both study groups: Weight.
timeFrame: 180 days
measure: To compare the changes in following parameters in both study groups: BMI.
timeFrame: 180 days
measure: To compare the changes in following parameters in both study groups: HOMA IR .
timeFrame: 180 days
measure: To compare the changes in following parameters in both study groups: Lipid profile.
timeFrame: 180 days
measure: To compare the adherence to IMD, with the help of Modified KIDMED score.
timeFrame: 180 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: