Effect of Indo-Mediterranean Diet on Hepatic Steatosis and Fibrosis in NAFLD Children
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

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.
    

Detailed description: 
      During the last decade, Nonalcoholic fatty liver disease (NAFLD) has become the most common
      cause of chronic hepatopathies in children and adolescents. NAFLD is considered as the
      hepatic manifestation of metabolic syndrome (MetS) and is defined as fat accumulation in the
      liver of patients who do not consume excessive amounts of alcohol. The mechanism of liver
      injury in NAFLD is considered to be a "Multiple hit process". The first "hit" leads to an
      increase in liver fat, while the next multiple factors lead to inflammation. In Developed
      countries, 4 to 11% of the general pediatric population is affected by NAFLD, reaching a rate
      of 70% among overweight and obese children. Lifestyle modification consisting of diet,
      exercise and weight loss has been proven to treat patients with NAFLD. Mediterranean diet
      (MD) has been largely evaluated for its beneficial effects in terms of prevention of obesity
      and MetS. Mediterranean diet is a nutritional model which has its origins in stated
      surrounding the Mediterranean Sea. MD patterns may vary among countries and regions owing to
      the cultural, ethnic, religious and agricultural differences. MD usually consists of eating
      primarily unrefined cereals, vegetables and fresh fruit, olive oil, nuts; eating fish, white
      meat, dairy products in moderation; limiting red meat, processed meats and sweets. MD helps
      to decrease hepatic fat by decreasing lipogenesis, fibrogenesis, inflammation, oxidative
      stress and by increasing fatty acids beta oxidation. MD is based on compounds, such as
      polyphenols, vitamins and other biomolecules that have anti inflammatory and antioxidant
      effects. It also has carotenoids and lycopenes which act as antioxidants. MD is characterized
      by high Mono unsaturated fatty acids content with a balanced Poly unsaturated fatty acids
      omega¬6 to omega¬3 ratio due to the abundance of vegetables, legumes, nuts, olive oil and
      fish (instead of red meats). 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 only two studies in children on the association between NAFLD and Mediterranean
      diet. Cakir et al first analysed in obese youth the association between MD adherance {as
      assessed by the Mediterranean diet quality index (KIDMED)} and NAFLD (as diagnosed by
      ultrasound and /or elevated ALT levels, as well exclusion of other causes of fatty liver).
      The authors evaluated overweight/obese children with (n=106) and without (n=21) NAFLD, as
      well as children (n=54) with normal BMI and without known chronic disease.Subjects with a low
      MD adherence were more likely to present with a higher BMI, though no correlation was found
      with other parameters including steatosis severity. Another study by Della Corte et al
      analysed the adherence to MD {as assessed by the Mediterranean diet quality index(KIDMED)
      score} in 243 overweight/obese youths with and without NAFLD. Of these, 100 underwent live
      biopsy. Poor adherance to MD was related to severity of liver damage as well as to higher
      levels of C-reactive Protein, Insulin and Homeostatic Model Assessment of Insulin Resistance
      (HOMA IR) values, thus suggesting increased inflammatory potential of unhealthy diets. In the
      Indian scenario, it will be very difficult to follow Mediterranean diet, so a concept of
      Indo-Mediterranean was diet was introduced in a study by Singh et al. Total 499 patients were
      allocated to a Indo -Mediterranean diet rich in whole grains, fruits, vegetables, walnuts,
      and almonds. 501 controls consumed a local diet similar to the step I National Cholesterol
      Education Program (NCEP) prudent diet. It was seen that there was significant reduction in
      serum cholesterol concentration and other risk factors in both groups, but especially in the
      intervention diet (Indo -Mediterranean) group. Indo-Mediterranean diet was shown to reduce
      sudden cardiac death, Myocardial infarction, weight and BMI in Obese adults on follow up. In
      a study by Bharti et al, it was seen that Olive oil and Mustard oil are comparable and infact
      Mustard oil is suitable for Indian cooking settings, hence mustard oil can be used as instead
      of olive oil in Indo -Mediterranean diet. In summary, MD diet has been shown to be useful in
      NAFLD patients, also there is very limited data in pediatric literature about the advantages
      of MD in NAFLD children. The investigators aim 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.
    

Intervention name(s): Indo Mediterranean diet; Calorie restricted diet
Intervention type(s): Other; Other
Intervention description(s): 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.; One group will be given diet restricted in calories, which most of the patients follow to lose weight
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Single centre Open label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NAFLD; Indo-Mediterranean diet; Calorie restricted diet