Health Condition 1: null- SUBJECTS WITH CORONARY ARTERY DISEASE AND SUBJECTS WITHOUT CORONARY ARTERY DISEASE HAVING HDL LESS THAN 40 mg/dl IN MALES AND HDL LESS THAN 50mg/dl IN FEMALES.
Conditions
Interventions
Intervention1: Virgin coconut oil 4gmis administered daily and is followed up for 6 months
: Virgin coconut oil 4gm is administered daily and is followed up for 6 months
Group 1.Dyslipidemic patie
Sponsors
COCONUT DEVELOPMENT BOARD
Eligibility
Inclusion criteria
Inclusion criteria: INCLUSION FOR CAD PATIENTS 1.MALE/FEMALE OF 18 YEARS OF AGE. 2SIGNIFICANT CAD IN AT LEAST ONE OF THE EPICARDIAL CORONARY ARTER CONFIRMED BY ANGIOGRAPHY. 3.PREVIOUS MI OR ACUTE CORONARY SYNDROME NOT LESS THAN 3 MONTHS DURATION. 4.OBJECTIVE EVIDENCE OF MYOCARDIAL ISCHEMIA WITH SYMPTOMS ON TRATMENT 5.MDCT EVIDENCE OF CAD 6.PATHOLOGICAL Q WAVES IN ECG AND OR RWMA IN ECHO 7.LOW HDL 8SUBJECTS WILLING TO COMPLY WITH ALL FOLLOW-UP VISITS. 9.SUBJECTS SIGNED AND RECEIVED COPY OF INFORMED CONSENT FOR MAIN TRIAL. INCLUSION FOR NON-CAD PATIENTS 1.LOW HDL 2.SUBJECTS WILLING TO COMPLY WITH ALL FOLLOW-UP VISITS. 3.SUBJECTS SIGNED AND RECEIVED COPY OF INFORMED CONSENT FOR MAIN TRIAL.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA FOR CAD AND NON-CAD SUBJECTS 1.UNTREATED HYPOTHYROIDISM AND UNCONTROLLED DIABETES MELLITUS 2.PREEXISTING MAL ABSORPTION SYNDROME 3.SEVERE CONGESTIVE HEART FAILURE AT THE TIME OF ENROLLEMENT. 4.DIETARY PATTERN/DOMESTIC DIETETIC ENVIRONMENT, UNSUITABLE FOR TRIAL DESIGN. 5.ABNORMAL RENAL FUNCTION WITH CREATININ GREATER THAN 2.0 Mg/dl & OR CREATININE CLEARENCE 6.SGOT/SGPT GREATER THAN 3TIMES THE REFERENCE RAGE AT THE ENTRY. 7.EXTRA CARDIAC ILLNESS THAT IS EXPECTED TO LIMIT SURVIVAL TO LESS THAN 2 YEARS. 8.PATIENT ON MEDICATIONS THAT AFFECT ENDPOINTS OF THE STUDY 9.PREGNANCY OR WOMEN OF CHILD BEARING POTENTIAL WITH INADEQUATE CONTRACEPTION 10.CONCURRENT ENROLMENT IN ANOTHER CLINICAL TRIAL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.TO ASSESS THE HDL CHOLESTEROL RAISING PROPERTY OF VCO. 2.TO ASSESS THE ANTIOXIDANT PROPERTY OF VCO. 3.TO ASSESS THE INFLUENCE OF VCO ON Apo B/A RATIO.Timepoint: 1.TO ASSESS THE HDL CHOLESTEROL RAISING PROPERTY OF VCO. 2.TO ASSESS THE ANTIOXIDANT PROPERTY OF VCO. 3.TO ASSESS THE INFLUENCE OF VCO ON Apo B/A RATIO. TIME POINT ONE FOR SAFETY 1 MONTH. 3RD AND 6TH MONTH PRIMARY AND SECONDARY OUTCOME. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of virgin coconut oils on Diabetes and inflammatory markers. To test the statistical significance of the changes in various parameters, on an average between the two groups, from baseline to different point of time between CAD and Non â??CAD group-Studentâ??s t test will be applied. Timepoint: At baseline,1month [safety],3 month and 6 months | — |
Countries
India
Contacts
Public ContactDr MANIYAL VIJAYAKUMAR
AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
Outcome results
None listed