Fighting Fatty Liver in India
FFL
Fighting the Fatty Liver Pandemic: Developing Effective Protocols & Local Expertise to Deliver & Evaluate Diet/Lifestyle Interventions for Better Liver & Metabolic Health in India
1 other identifier
interventional
84
1 country
1
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 intervention delivery, dietary evaluation, and biochemical analyses, using available local resources in Kerala.
- 2.Training and enhancing imaging skills of clinical radiographers in Kerala for research studies
- 3.Training local professionals and researchers in skills necessary to design, deploy and evaluate diet/lifestyle interventions, including patient engagement, in Kerala.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 18, 2019
February 1, 2019
7 months
February 11, 2019
February 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in liver fat
Measured by MRI, comparing liver fat pre- and post-intervention.
1 year
Secondary Outcomes (3)
Change in body composition
1 year
Change in body composition
1 year
Change in insulin sensitivity
1 year
Study Arms (2)
Diet change (red rice) with yoga
EXPERIMENTALFollowing randomisation, participants are given a schedule of group and personal meetings and details of each session. Food for the diet (red rice and lentils) will be provided for those randomised to the diet arm. The study will last 16 weeks following start of the diet/yoga programme. There will be further visits to measure outcomes at week 8 and week 16. All participants in both arms will complete the same programme of Yoga sessions, organized and delivered by experienced practitioners under direction of Dr Leena Mohan at the Holistic Health and Research Institute.
Yoga
ACTIVE COMPARATORFollowing randomisation, participants are given a schedule of group and personal meetings and details of each session. The study will last 16 weeks following start of the diet/yoga programme. There will be further visits to measure outcomes at week 8 and week 16. All participants in both arms will complete the same programme of Yoga sessions, organized and delivered by experienced practitioners under direction of Dr Leena Mohan at the Holistic Health and Research Institute.
Interventions
This interventions specifically aims to reduce liver inflammation, by replacing white rice in the diet with equal amounts of red rice and lentils. This will also enable for the research team to tests specific scientific hypotheses regarding the effects of diet on insulin resistance, liver pathology and the gut microbiome in NAFLD.
All 84 study participants take part in the yoga intervention. This is an intensive programme organized and delivered by experienced practitioners under direction of Dr Leena Mohan at the Holistic Health and Research Institute. This will evaluate whether physical activity alone improves metabolic health of the liver.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Population Health and Research Institute
Trivandrum, Kerala, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The participant and study team will not be blinded to this allocation, although the scientist and radiology team will be blinded when analysing samples/scans.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 18, 2019
Study Start
January 1, 2019
Primary Completion
July 31, 2019
Study Completion
December 31, 2019
Last Updated
February 18, 2019
Record last verified: 2019-02