FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/026043 [Registered on: 22/06/2020] Trial Registered Prospectively
Last Modified On: 16/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Intermittent Fasting ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   YOGIC FAST ATHEROSCLEROSIS REGRESS IVUS STUDY  
Scientific Title of Study   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  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science , Rishikesh  
Address  Room Number 25103 Department of Cardiology All India Institute of Medical Science Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science , Rishikesh  
Address  Room Number 25103 Department of Cardiology All India Institute of Medical Science Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Rohit Walia  
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science , Rishikesh  
Address  Room Number 25103 Department of Cardiology All India Institute of Medical Science Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Science Rishikesh  
 
Primary Sponsor  
Name  Rohit Walia  
Address  Room number 25103, Department of Cardiology All India Institute of Medical science Rishikesh Uttarakhand  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohit Walia   All India Institute of Medical science , Rishikesh   Room number 25103 , Department of Cardiology
Dehradun
UTTARANCHAL 		 8800492549

rwalia7731@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Science Rishikesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Adlibium intake no time restriction no fasting   No time restricted fasting and one a fifteen day fasting as in intervention group  
Intervention  Intermittent Fasting   Intermittent fasting or time restricted eating after sunrise approximately 6 am and between sunset approx 6 pm and daily 12 hours night fasting and one a day in 15 days one meal fast . It has numerous benefits in reducing insulin resistance , inflammation , lipids and obesity.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in participant plague volume
Change from baseline in participant culprit lesion and in stent restenosis
Change from baseline in participant plague tissue component percentage change at one year : Percentage change in necrotic , fibrotic , lipid and calcific tissue volume
Number of plagues regressed , progressed and new plagues
Difference in cardiac events between both groups
Incidence of new onset diabetes  		 1 year  
 
Secondary Outcome  
Outcome  TimePoints 
Change in visceral fat , lipid profile , insulin resistance , CRP , neutrophil/lymphocytr ratio to plague volume and composition



 		 1 year  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.





 
Close