NAFLDFFLNCT03844165
Fighting Fatty Liver in India
A study testing Diet change (red rice) and Yoga in people with NAFLD, run by University of Nottingham at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- NAFLD
- What is being tested?
- Diet change (red rice) and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Population Health and Research Institute
Trivandrum, Kerala
Thrivikrama Shenoy, dr.ktshenoy@gmail.com
Leena Mohan, leenakb@yahoo.com
About this study
Official title: Fighting the Fatty Liver Pandemic: Developing Effective Protocols & Local Expertise to Deliver & Evaluate Diet/Lifestyle Interventions for Better Liver & Metabolic Health in India
This study aims to build capacity in India by:
- 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.
- Training and enhancing imaging skills of clinical radiographers in Kerala for research studies
- Training local professionals and researchers in skills necessary to design, deploy and evaluate diet/lifestyle interventions, including patient engagement, in Kerala.
This study will deliver and evaluate a simple dietary intervention pilot study in the Kerala region in conjunction with local nutritionists, healthcare professionals and partner researchers at PHRI (Population Health and Research Institute, Trivandrum, Kerala, India).
Read the 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 progressive form, non-alcoholic steatohepatitis (NASH), has been estimated to affect 1.5%-6.5% of the population with associated increased risk of cirrhosis, hepatocellular carcinoma and liver-specific mortality. Considering the key association of fat accumulation within the liver, in particular diacyl glycerols, to the generation of whole body insulin resistance and development of type 2 diabetes, NAFLD has been considered a pre-diabetic state. NAFLD has been associated with excess risk of non-fatal and fatal cardiovascular events independently of established co-morbidities including type 2 diabetes, dyslipidemia and obesity. Individuals of South Asian ethnicity have significantly higher rates of NAFLD, abdominal obesity and cardiovascular disease than whites and ethnicity is a risk factor for NAFLD independent of diabetes, BMI, hypertension and hypercholesterolemia.
NAFLD problem in India:
Consistent with the global trend, the health and economic burdens of metabolic syndrome and NAFLD have risen in India. In 2011, India had 63 million individuals with type 2 diabetes and by 2030, that number is predicted to be a staggering 90 million. Insulin resistance (IR) has also been shown to be more prevalent in Indians compared with other ethnic groups and this has been correlated with NAFLD regardless of adiposity. Despite these links, there are a number of key differences between Indian NAFLD patients and those in the West: mean BMI is significantly lower in Indians and there is also a lower prevalence of hypertension, diabetes and metabolic syndrome in non-cirrhotic NAFLD patients.
Dietary influences on NAFLD:
Diet may be one of the key environmental factors that accounts for ethnic variation in susceptibility to NAFLD. However, there is currently a lack of research into specific dietary factors influencing susceptibility to NAFLD, in particular, with regards to macronutrients, and there are few evidence-based dietary interventions, beyond energy restriction to induce weight loss. Considering the effectiveness of a modest increase in protein content and a reduction in the glycaemic index (GI) in maintaining weight loss, we investigated the effects of a low GI diet on the liver and demonstrated that it did not increase liver fat content whereas an increase was seen with an isoenergetic high GI diet controlled for macronutrient content.
Diet has been found to influence the gut microbiome variably across human societies. Fibre encompassing a range of characteristics, is one of the fundamental components linking diet, the gut microbiome and fatty acid metabolism. The benefits of dietary fibre include improved glucose homeostasis and insulin sensitivity. Dietary fibres are at least partly fermented in the caecum and large intestine by the colonic microbiota resulting in some cases an increased production of short chain fatty acids (SCFAs) which regulate the balance between fatty acid synthesis, fatty acid oxidation and lipolysis in the body. The net result is a reduction in free fatty acid concentrations in plasma and a decrease in body weight. Dietary fibre overall is associated with greater gut microbiome diversity and we have recently shown that it is also associated with lower long-term weight gain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet change (red rice)Behavioural
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.
YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet change (red rice) with yoga | Experimental | Following 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. Receives: Behavioral: Diet change (red rice); Behavioral: Yoga |
| Yoga | Active comparator | Following 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. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat
Measured by MRI, comparing liver fat pre- and post-intervention.
Measured: 1 year
Secondary outcomes (3)
Change in body composition
Measured by body fat % via bioimpedance
Measured: 1 year
Change in body composition
Measured by BMI (kg/m2)
Measured: 1 year
Change in insulin sensitivity
Measured by oral glucose tolerance test (OGTT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Jan 2019
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Dec 2019 (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 University of NottinghamThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is two-arm dietary interventional study that will be conducted through the Population Health and Research Institute, Trivandrum, India. Participants will be randomised to one of two study arms: diet change with yoga or yoga. We will aim to recruit 42 participants to each arm.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health and Research Institute, Trivandrum, Kerala, india, Holistic Health and Research Institute, Trivandrum, Kerala, India
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844165
- Sponsor's protocol ID
- 137 1811
- Acronym
- FFL
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fighting the Fatty Liver Pandemic: Developing Effective Protocols & Local Expertise to Deliver & Evaluate Diet/Lifestyle Interventions for Better Liver & Metabolic Health in India
- ClinicalTrials.gov ID
- NCT03844165
- Acronym / sponsor ID
- FFL / 137 1811
- Conditions
- NAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Population Health and Research Institute, Trivandrum, Kerala, india, Holistic Health and Research Institute, Trivandrum, Kerala, India
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Feb 2019 (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.
This study aims to build capacity in India by:
- 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.
- Training and enhancing imaging skills of clinical radiographers in Kerala for research studies
- Training local professionals and researchers in skills necessary to design, deploy and evaluate diet/lifestyle interventions, including patient engagement, in Kerala.
This study will deliver and evaluate a simple dietary intervention pilot study in the Kerala region in conjunction with local nutritionists, healthcare professionals and partner researchers at PHRI (Population Health and Research Institute, Trivandrum, Kerala, India).
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 progressive form, non-alcoholic steatohepatitis (NASH), has been estimated to affect 1.5%-6.5% of the population with associated increased risk of cirrhosis, hepatocellular carcinoma and liver-specific mortality. Considering the key association of fat accumulation within the liver, in particular diacyl glycerols, to the generation of whole body insulin resistance and development of type 2 diabetes, NAFLD has been considered a pre-diabetic state. NAFLD has been associated with excess risk of non-fatal and fatal cardiovascular events independently of established co-morbidities including type 2 diabetes, dyslipidemia and obesity. Individuals of South Asian ethnicity have significantly higher rates of NAFLD, abdominal obesity and cardiovascular disease than whites and ethnicity is a risk factor for NAFLD independent of diabetes, BMI, hypertension and hypercholesterolemia.
NAFLD problem in India:
Consistent with the global trend, the health and economic burdens of metabolic syndrome and NAFLD have risen in India. In 2011, India had 63 million individuals with type 2 diabetes and by 2030, that number is predicted to be a staggering 90 million. Insulin resistance (IR) has also been shown to be more prevalent in Indians compared with other ethnic groups and this has been correlated with NAFLD regardless of adiposity. Despite these links, there are a number of key differences between Indian NAFLD patients and those in the West: mean BMI is significantly lower in Indians and there is also a lower prevalence of hypertension, diabetes and metabolic syndrome in non-cirrhotic NAFLD patients.
Dietary influences on NAFLD:
Diet may be one of the key environmental factors that accounts for ethnic variation in susceptibility to NAFLD. However, there is currently a lack of research into specific dietary factors influencing susceptibility to NAFLD, in particular, with regards to macronutrients, and there are few evidence-based dietary interventions, beyond energy restriction to induce weight loss. Considering the effectiveness of a modest increase in protein content and a reduction in the glycaemic index (GI) in maintaining weight loss, we investigated the effects of a low GI diet on the liver and demonstrated that it did not increase liver fat content whereas an increase was seen with an isoenergetic high GI diet controlled for macronutrient content.
Diet has been found to influence the gut microbiome variably across human societies. Fibre encompassing a range of characteristics, is one of the fundamental components linking diet, the gut microbiome and fatty acid metabolism. The benefits of dietary fibre include improved glucose homeostasis and insulin sensitivity. Dietary fibres are at least partly fermented in the caecum and large intestine by the colonic microbiota resulting in some cases an increased production of short chain fatty acids (SCFAs) which regulate the balance between fatty acid synthesis, fatty acid oxidation and lipolysis in the body. The net result is a reduction in free fatty acid concentrations in plasma and a decrease in body weight. Dietary fibre overall is associated with greater gut microbiome diversity and we have recently shown that it is also associated with lower long-term weight gain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is two-arm dietary interventional study that will be conducted through the Population Health and Research Institute, Trivandrum, India. Participants will be randomised to one of two study arms: diet change with yoga or yoga. We will aim to recruit 42 participants to each arm.
| Arm | Type | Receives |
|---|---|---|
| Diet change (red rice) with yoga | Experimental | Behavioral: Diet change (red rice), Behavioral: YogaFollowing 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 comparator | Behavioral: YogaFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
- 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
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 |
|---|---|---|
| Diet change (red rice)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. | Behavioural | Diet change (red rice) with yoga |
| YogaAll 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. | Behavioural | Diet change (red rice) with yoga, Yoga |
Primary outcome
Change in liver fat
Time frame: 1 year
Measured by MRI, comparing liver fat pre- and post-intervention.
3 secondary outcomes
Change in body composition
Time frame: 1 year
Change in body composition
Time frame: 1 year
Change in insulin sensitivity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet change (red rice) and Yoga in people with NAFLD, run by University of Nottingham 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 9 inclusion and 13 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 18 Feb 2019. 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 Guruprasad P Aithal (01158231149, guru.aithal@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver fat (time frame: 1 year). 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 18 Feb 2019.