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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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:
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To compare the changes in CAP values after 180 days of IMD versus LFD in children and adolescent with MASLD.
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To compare the grades of Fatty liver on Ultrasonography after 180 days between the two study groups.
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To compare the changes in CAP value in PNPLA3 mutant children.
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To study the change in Adiponectin, Cytokines(TNF alpha, IL 6, IL-1β, and IL-17) after 180 days between the two study groups.
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To compare the changes in following parameters in both study groups: Weight, BMI, HOMA IR and Lipid profile.
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To compare the adherence to IMD, with the help of Modified KIDMED score.
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Study design: Prospective, Randomized, Single center Open label study.
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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 :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 8-18 years
- •BMI > 85th centile
Exclusion Criteria
- •- Other Liver diseases such as Viral hepatitis (Hep B and C), Autoimmune hepatitis, Wilson disease.
Arms & Interventions
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),
Intervention: Indianized version of Mediterranean Diet (Other)
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),
Intervention: Physical Activity (Other)
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.
Intervention: Low Fat Diet (Other)
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.
Intervention: Physical Activity (Other)
Outcomes
Primary Outcomes
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.
Time Frame: 180 days
Secondary Outcomes
- 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)