a) Aim and Objective - Primary Objectives
• To study the effect of millets based diet on hepatic steatosis in patients with NAFLD
Secondary Objective:
* To study the effect of millets based diet on metabolic features like blood sugar levels, HbA1C, Insulin resistance, Lipid profile, and liver transaminases in patients with NAFLD.
* To study the effect of millets based diet on body composition in patients with NAFLD
* To study the effect of millets based diet on the profile of gut microbiota in patients with NAFLD (b) Methodology:
* Study population: Out patients of departments of Hepatology and Clinical Nutrition, Institute of Liver and Biliary Sciences, New Delhi.
* Study design: Randomized Controlled Trial - an open label study
* Study Protocol: Newly diagnosed patients with non-alcoholic fatty liver (NAFL) attending the outpatient departments of Hepatology and Clinical Nutrition would be screened for eligibility for randomization into the study as per the inclusion and exclusion criteria. Thereafter the eligible patients would be randomized into the two groups - the control group (standard diet group) and the intervention group (Millets based diet group). All the patients would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, routine biochemical and hematological investigations, nutritional assessment. All the patients would be followed up at regular intervals in the OPD. Repeat assessment of all the parameters would be done at the end of intervention period of three months also.
* Study Duration: 2 yrs
* Follow up period: 3 months
* Inclusion Criteria:
* Recently diagnosed consenting adults with NAFL (steatotosis) of any grade with or without features of metabolic syndrome, diagnosed on the basis of ultrasound and /or liver transient eleastography (controlled attenuation parameter; CAP \>250).
* Age 18-60 years
* Exclusion Criteria:
* Pregnant \& lactating women
* Age \<18 and \>60 years
* Individuals who had been hospitalised with complications of Diabetes mellitus, Chronic Kidney disease, Hypertension in the previous 6 months
* Those with intake of antibiotics within last month
* Seriously ill and bed ridden patients
* Patients with viral hepatitis
* Patients with significant alcohol consumption (regular consumption of \> 10g per day for females and \> 20g/d in males),
* Patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded
* Patients with NAFLD with associated hypertriglyceridemia that requires administration of statins.
* Sample size with justification:
* As there is no literature available on the direct effect of Millets based diet on NAFLD, hence the present study would be a proof of concept study. The total sample size planned is 60 patients with NAFLD i.e. 30 patients each in the control and intervention group.
* Intervention: Nutritional Intervention with Millets including Ragi Flakes; Pearl Millet Flakes; Multi Millet Roti; Foxtail Millet Rice.
* Intervention Groups:Control Group A (Standard Diet Group): This group would receive standard nutritional counselling with customized diet providing 20-25 Kcal/Kg and 1.0 gm protein/kg ideal body wt/day. 15-20% of the total calories as proteins, 50-60% of carbohydrates (Main Source: Wheat, Rice, Oats) and 25-30% of fats. Diet would be planned keeping in mind the individual food habits and choices. This group would not receive any nutritional supplement other than the prescribed diet.
* Intervention Group B (Millets Diet Group): This group would receive standard nutritional counselling, customized diet providing 20-25 Kcal/Kg and 1.0 gm protein/kg ideal body wt/day. 15-20% of the total calories as proteins, 50-60% of carbohydrates (Main Source: Pearl millet flakes/Foxtail millet rice/multi millet roti) and 20-25% of fats. Diet would be planned keeping in mind the individual food habits and choices. This group would not receive any nutritional supplement other than the prescribed diet.
* Physical activity recommendations: Brisk walking on a treadmill (at a speed 5-6 Kmph for 45 minutes) OR 5000 steps per day by pedometer counting
* Duration of Intervention: Diets would be given for a period of three months.
* Stopping rule for intervention:
* Temporary Stopping Rules during the Study
1. Non-compliance
2. Allergic response to millets intervention
3. Voluntary withdrawal.
