DOES YOGIC PATTERN OF INTERMITTENT FASTING AND YOGIC DIET REGRESS ATHEROSCLEROSIS IN CORONARY ARTERY DISEASE PATIENTS IN ADDITION TO CONVENTIONAL MEDICAL THERAPY : AN OBJECTIVE INTRAVASCULAR ULTRASOUND BASED STUDY :YOGIC FAST ATHEROSCLEROSIS REGRESS IVUS STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Rohit Walia
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline in participant plague volume
研究概览
简要总结
Hypothesis : Intermittent fasting facilitates weight loss improves coronary artery disease risk factors like low density lipoproteins , triglycerides , small low density lipoproteins , insulin resistance, inflammation , new onset diabetes. Atherosclerosis is characterised by lipotoxicity , inflammation and intermittent fasting may regress or stabilise the disease by above mentioned mechanism and by inducing autophagy.
Stable overweight non diabetic stable coronary artery disease patients requiring coronary angiography and intravascular ultrasound will be enrolled in Yogic Satvik diet and time restricted intermittent fasting daily ( two times meal between 6 am and 6 pm ) and fast once every eleventh day with one meal of 250 Kcal between 8 am and 2 pm along with conventional recommended medical therapy vs. medical therapy alone for one year. The participants will be analysed long term for coronary atherosclerosis plague reduction and composition using intravascular ultrasound and endocrine , immune , cardiovascular , metabolic effects of long term intermittent fasting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 40 to 60 years males Stable Coronary artery disease patients referred for percutaneous intervention in an artery suitable for intravascular ultrasound pullback Non diabetic Non Smokers Left ventricular ejection fraction greater than 45 percent Body mass index greater than 25.
排除标准
- •Left main disease More than moderate left ventricular systolic dysfunction ( LVEF<45%) Deranged Renal Function Test Chronic Liver Disease Advanced Malignancy Severe chronic obstructive pulmonary disease Any addiction Not willing to give consent Hypothyroid or hyperthyroid disorders Body mass index < 25 Infectious diseases Peptic ulcer Bleeding disorder Need for coronary artery bypass grafting Hemodynamically unstable patients Gout Celiac disease Anemia Specific Food allergy Failure to advance IVUS catheter through culprit lesion Heavily calcified vessels Previous Percutaneous coronary intervention / Coronary artery bypass grafting Anorexia nervosa Bulimia Pregnancy Lactation Athletes , high intensity sports , body building Any recent hospitalisation in past 3 months The patient has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the FDA-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.
- •Treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
- •Diabetes or use of insulin Migraine Epilepsy.
结局指标
主要结局
Change from baseline in participant plague volume
时间窗: 1 year
Change from baseline in participant culprit lesion and in stent restenosis
时间窗: 1 year
Change from baseline in participant plague tissue component percentage change at one year : Percentage change in necrotic , fibrotic , lipid and calcific tissue volume
时间窗: 1 year
Number of plagues regressed , progressed and new plagues
时间窗: 1 year
Difference in cardiac events between both groups
时间窗: 1 year
Incidence of new onset diabetes
时间窗: 1 year
次要结局
- Change in visceral fat , lipid profile , insulin resistance , CRP , neutrophil/lymphocytr ratio to plague volume and composition