NAFLDNCT06341790
Effect of Consumption of Millet Diet in Patients With NAFLD
A study testing jowar based products in people with NAFLD, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- NAFLD
- What is being tested?
- jowar based products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2024to 5 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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
Who cannot join
- - 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
ILBS
New Delhi, 110070
Nida Athar, Msc, 8601079163, nidaathar.20@gmail.com
About this study
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
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 .
Read the detailed description
- 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
- Non-compliance
- Allergic response to millets intervention
- Voluntary withdrawal.
- Conditions
- NAFLD
- Being tested
- jowar based products
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
jowar based productsOther
jowar based products like jowar flakes, jowar aata, jowar vermicelli is given to the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Group A-Normal diet | No intervention | patients are advised normal diet for NAFLD |
| Group b-Millet Diet | Experimental | Patients are given millets based diet (jowar) Receives: Other: jowar based products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hepatic steatosis in NAFLD patients
Change in hepatic steatosis as assessed by fibroscan, ultrasound (change in the CAP, LSM)
Measured: 3months
Secondary outcomes (5)
Assessment of blood sugar
Change in blood sugar as assessed by blood fasting glucose, serum insulin \& HbA1c
Measured: 3months
Assessment of lipid function
Change in lipid parameters as assessed by blood lipid profile test
Measured: 3 months
Assessment of liver transaminases
Change in liver enzymes as assessed by liver function tests
Measured: 3 months
Assessment of body composition
Change in Nutritional status will be assessed using bioelectrical impedence analysis
Measured: 3 months
Assessment of Gut Microbiota
Change in gut microbiota will be assessed using 16S dNA extraction
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion5 Jul 2026 (estimated)
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Jaya Joy Benajmin, Phd, Principal investigator, Associate Professor, Clinical Nutrition at the Institute of Liver and Biliary Sciences (ILBS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341790
- Sponsor's protocol ID
- NAFLD-02
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06341790
- Acronym / sponsor ID
- NAFLD-02
- Conditions
- NAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
- 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
- Non-compliance
- Allergic response to millets intervention
- Voluntary withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A-Normal diet | No intervention | –patients are advised normal diet for NAFLD |
| Group b-Millet Diet | Experimental | Other: jowar based productsPatients are given millets based diet (jowar) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- - 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
Key exclusion criteria (9 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| jowar based productsjowar based products like jowar flakes, jowar aata, jowar vermicelli is given to the intervention group | Other | Group b-Millet Diet |
Primary outcome
Assessment of hepatic steatosis in NAFLD patients
Time frame: 3months
Change in hepatic steatosis as assessed by fibroscan, ultrasound (change in the CAP, LSM)
5 secondary outcomes
Assessment of blood sugar
Time frame: 3months
Assessment of lipid function
Time frame: 3 months
Assessment of liver transaminases
Time frame: 3 months
Assessment of body composition
Time frame: 3 months
Assessment of Gut Microbiota
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Jaya Joy Benajmin, Phd principal investigator
Associate Professor, Clinical Nutrition at the Institute of Liver and Biliary Sciences (ILBS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing jowar based products in people with NAFLD, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nida Athar, M.Sc (8601079163, nidaathar.20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hepatic steatosis in NAFLD patients (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.