Status:
UNKNOWN
Fighting Fatty Liver in India
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Population Health and Research Institute, Trivandrum, Kerala, india
Holistic Health and Research Institute, Trivandrum, Kerala, India
Conditions:
NAFLD
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This study aims to build capacity in India by: 1. Developing tailored protocol methodologies for research including technical capability in imaging (MRI/S protocols \& customised software), dietary i...
Detailed Description
STUDY BACKGROUND INFORMATION AND RATIONALE Non-alcoholic fatty liver disease (NAFLD): With an estimated global prevalence of 25% among adults, NAFLD is now the commonest chronic liver disease; its p...
Eligibility Criteria
Inclusion
- Inclusion criteria
- aged 18 years or over
- Male
- Able to give informed consent
- NAFLD diagnosis showing Fatty/echo-bright liver on ultrasound within past 3 months
- Able to attend yoga sessions
- Able to undergo MRI
- Consumer of at least 300g (uncooked weight) white rice per day (on average)
- No allergy to red rice or lentils
- Medically suitable for repeated blood sampling
- Exclusion criteria
- Known or suspected cirrhosis on clinical/histological/radiological grounds
- Current or recent history of significant alcohol consumption (\>14units per week)
- Other documented causes of chronic liver disease including:
- Hepatitis B or C infection
- Drug-induced liver disease
- Alcohol-related liver disease
- Autoimmune hepatitis
- Wilson's disease, Haemachromatosis
- Primary biliary cirrhosis, Primary Sclerosing Cholangitis
- Currently taking medication that can induce steatosis (corticosteroids, Amiodarone, Tamoxifen, Methotrexate)
- Evidence of any other unstable or untreated clinically significant immunological, endocrine, haematological, gastrointestinal, neurological, neoplastic or psychiatric disease
- \*Female
- A number of gender specific confounders (menstrual cycle, age etc) mean that mechanistic studies in small sample sizes are limited to men. The local cohort being used comprises males only.
Exclusion
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03844165
Start Date
January 1 2019
End Date
December 31 2019
Last Update
February 18 2019
Active Locations (1)
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1
Population Health and Research Institute
Trivandrum, Kerala, India