Fighting the Fatty Liver Pandemic: Developing Effective Protocols & Local Expertise to Deliver & Evaluate Diet/Lifestyle Interventions for Better Liver & Metabolic Health in India
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in liver fat
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Diet change (red rice) with yoga
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.
干预措施: Diet change (red rice) (Behavioral)
Diet change (red rice) with yoga
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.
干预措施: Yoga (Behavioral)
Yoga
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.
干预措施: Yoga (Behavioral)
结局指标
主要结局
Change in liver fat
时间窗: 1 year
Measured by MRI, comparing liver fat pre- and post-intervention.
次要结局
- Change in insulin sensitivity(1 year)
- Change in body composition(1 year)
