Clinical trial NCT05696808: Effect of Indian Hepatoprotective Diet in Reversibility of NAFLD
Official title: Effects of Indian Foods and Ayurvedic Drugs on Healthy and Diseased Liver
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Metabolic Syndrome
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All the variables would be studied before and after intervention with indian hepatoprotective diet (IHPD) in 60 patients with NAFLD and 60 healthy individuals on Western diet.
Primary purpose: TREATMENT

Brief summary: The modality of lifestyle modification including low calorie diets along with normal protein and moderate physical activity is the safest standard medical treatment for NAFLD in general. There are many benefits of weight loss to the patients with NAFLD. Besides the improvement in the features of metabolic syndrome, weight loss with IHPD would certainly improve the overall vitality and well being of the patients. The results of study will help to delineate a protocolized care for the management of NAFLD with metabolic syndrome thus helping other patients also in the future.

Detailed description: There is a strong link between food items, gut microbiota (GM), liver fat and development of various non-communicable diseases (NCDs). The incidence of NCDs is rapidly increasing globally. The GM is considered an organ by itself and any alterations in its composition or functioning are likely to be associated with different NCDs, including cancers. The core to most of the NCDs is increased fat in the liver and the non-alcoholic fatty liver disease (NAFLD). The highly variable natural history of NAFLD reflects the current incomplete understanding of the pathobiology of the disease. The strongest risk factors for NAFLD/NASH are unhealthy food items and their metabolites which affect the host and the gut microbiota.

Traditional Indian food items are known to have strong influence on liver and production of healthy bile, the 'Pitta'. The influence and health worthiness of various indigenous food items has not been scientifically evaluated. Their role in health and disease would not only help in prevention but also management of multiple non-communicable diseases. This information could also make a change in the social and behavioural attitudes of Indians

The proposed project would, therefore, undertake work on the following broad areas:

1. Effects of conventional Indian foods as hepatoprotective agents, producers of 'healthy' bile and stimulating liver regeneration.
2. Food constituents as therapeutic agents by changing dysbiotic gut microbiota to healthy microbiota, reduction in hepatic fat and inflammation, improving metabolic health (reducing sugar, cholesterol, etc.) and reduction in liver fibrosis

Eligibility criteria: Inclusion Criteria:

1. Patients recently diagnosed (\<3 months)diagnosed on the basis of ultrasound and /or liver transient eleastography (controlled attenuation parameter; CAP \>250)
2. Having components of metabolic syndrome like Hyperglycemia, central obesity, hypertension, hypertriglyceridemia, and low HDL cholesterol levels).

Exclusion Criteria:

1. Pregnant \& lactating women
2. Age \<18 and \>55 years
3. Individuals who had been hospitalised with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months
4. Those with intake of antibiotics within last month
5. Seriously ill and bed ridden patients
6. Patients with viral hepatitis
7. Patients with significant alcohol consumption (regular consumption of \> 10g per day for females and \> 20g/d in males),
8. Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded
9. Patients with NAFLD with associated hypertriglyceridemia requiring administration of statins.

Primary outcomes:
measure: To study the effectiveness of Indian Hepatoprotective Diet (IHPD) in hepatic steatosis in patients with NAFLD index in patients with NAFLD
timeFrame: 1 month
Secondary outcomes:
measure: To study the effectiveness of IHPD on Hyperglycemia (Fasting blood sugar) in patients with NAFLD
timeFrame: 1 month
measure: To study the effectiveness of IHPD on central obesity (waist circumference) in patients with NAFLD
timeFrame: 1 month
measure: To study the effectiveness of IHPD on hypertension (BP) in patients with NAFLD
timeFrame: 1 month
measure: To study the effectiveness of IHPD on hypertriglyceridemia in patients with NAFLD
timeFrame: 1 month
measure: To study the effectiveness of IHPD in reducing body weight in patients with NAFLD
timeFrame: 1 month
measure: To study the effectiveness of IHPD on gut microbiota in patients with NAFLD
timeFrame: 1 month
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences, New Delhi, India
name: Prof. Shiv Kr Sarin, MD, DM, FNA
role: PRINCIPAL_INVESTIGATOR
References: