Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341790
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-04
Brief Title:
Effect of Consumption of Millet Diet in Patients With NAFLD
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Effect of Consumption of Millets Based Diet on Clinical Characteristics Metabolic Profile and Gut Microbiome in Patients With Non-alcoholic Fatty Liver Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 mans 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
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 mans 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
Detailed Description:
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 20gd 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 ie 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 GroupsControl Group A Standard Diet Group This group would receive standard nutritional counselling with customized diet providing 20-25 KcalKg and 10 gm proteinkg ideal body wtday 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 KcalKg and 10 gm proteinkg ideal body wtday 15-20 of the total calories as proteins 50-60 of carbohydrates Main Source Pearl millet flakesFoxtail millet ricemulti 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
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 20gd 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 ie 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 GroupsControl Group A Standard Diet Group This group would receive standard nutritional counselling with customized diet providing 20-25 KcalKg and 10 gm proteinkg ideal body wtday 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 KcalKg and 10 gm proteinkg ideal body wtday 15-20 of the total calories as proteins 50-60 of carbohydrates Main Source Pearl millet flakesFoxtail millet ricemulti 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None