Effect of Consumption of Millet Diet in Patients With NAFLD

NCT06341790 | Not Yet Recruiting

• 1 other identifier: NAFLD-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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 .

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• Assessment of hepatic steatosis in NAFLD patients

  Change in hepatic steatosis as assessed by fibroscan, ultrasound (change in the CAP, LSM)

  3months

Secondary Outcomes (5)

• Assessment of blood sugar

  3months

• Assessment of lipid function

  3 months

• Assessment of liver transaminases

  3 months

• Assessment of body composition

  3 months

• Assessment of Gut Microbiota

  3months

Study Arms (2)

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)

Other: jowar based products

Interventions

jowar based products OTHER

jowar based products like jowar flakes, jowar aata, jowar vermicelli is given to the intervention group

Group b-Millet Diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

ILBS

New Delhi, 110070, India

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Dr Jaya Joy Benajmin, Phd

  Associate Professor, Clinical Nutrition at the Institute of Liver and Biliary Sciences (ILBS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nida Athar, M.Sc

CONTACT

8601079163; nidaathar.20@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: April 2, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)