Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05073588 |
| Other study ID # |
ILBS-NAFLD-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2021 |
| Est. completion date |
March 30, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Institute of Liver and Biliary Sciences, India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
