An interventional study of jowar based products in NAFLD, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
With NAFLD fast rising its ranks in becoming a major non communicable disease in India and across the globe, this study aims at primary prevention of the condition. NAFLD is a spectrum of diseases characterised by the deposition of fat within hepatocytes and is a precursor of liver inflammation. Global estimates peg the prevalence to be around 30 to 40%, but there are not many studies which have documented the prevalence in India. With the epidemiological transition, the cases of NAFLD are also on a rise as metabolic syndrome is an important risk factor.
It is apparent that the westernized way of our lifestyle especially the junk food culture comprising of super portions of loads of calories, sugars and salts is the main driver of this nutritional pandemic. The traditional diets in India were rich in fruits and vegetables, low in simple carbohydrates and high in fibre. Cereals are the main source of calories in any diet, forming the base of the food pyramid. Managing our cereals from being refined to the more complex ones being rich in fibre, protein and good quality fat could be a major player in the whole game of dietary modifications not just therapeutically but also prophylactically. Hence our therapeutic focus should be in increasing the consumption of cereals that are not only high in fibre, low in carbohydrates but also that have the potential to modulate the intestinal bacterial ecology to a more favourable type thus helping in intensifying the effects of overall dietary modifications.
Gut microbiota is currently explored for its role in NAFLD and there are gaps in knowledge which preclude having therapeutic strategies through its modulation. Millets, which were once considered to be poor man's diet are now becoming a part of the plate more frequently, especially for its unique nutritive content, with increased fiber, low carbohydrates, high protein and good quality fats. The processing methods may alter glycemic responses. Thus, the present study is proposed to look into the effect of millet based diets in reduction of hepatic steatosis and the resultant alterations in the gut microbiota .
a) Aim and Objective - Primary Objectives
Secondary Objective:
To study the effect of millets based diet on the profile of gut microbiota in patients with NAFLD (b) Methodology:
Temporary Stopping Rules during the Study
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients are advised normal diet for NAFLD
Patients are given millets based diet (jowar)
Other: jowar based products
jowar based products like jowar flakes, jowar aata, jowar vermicelli is given to the intervention group
Assessment of hepatic steatosis in NAFLD patients
Change in hepatic steatosis as assessed by fibroscan, ultrasound (change in the CAP, LSM)
Time frame: 3months
Assessment of blood sugar
Change in blood sugar as assessed by blood fasting glucose, serum insulin \& HbA1c
Time frame: 3months
Assessment of lipid function
Change in lipid parameters as assessed by blood lipid profile test
Time frame: 3 months
Assessment of liver transaminases
Change in liver enzymes as assessed by liver function tests
Time frame: 3 months
Assessment of body composition
Change in Nutritional status will be assessed using bioelectrical impedence analysis
Time frame: 3 months
Assessment of Gut Microbiota
Change in gut microbiota will be assessed using 16S dNA extraction
Time frame: 3months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
Institute of Liver and Biliary Sciences, India