Effect of virgin coconut oil as a dietary supplement on lipid profile and oxidative stress in dyslipidemic individuals with low high density lipoproteins [ HDL].A 6 months follow up study in patients with and without CAD.
- Conditions
- 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.
- Registration Number
- CTRI/2015/04/005678
- Lead Sponsor
- COCONUT DEVELOPMENT BOARD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
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 <40 mg/dL IN MALES AND <50 mg/dL IN FEMALES.
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 <40 mg/dL IN MALES AND <50 mg/dL IN FEMALES.
2.SUBJECTS WILLING TO COMPLY WITH ALL FOLLOW-UP VISITS.
3.SUBJECTS SIGNED AND RECEIVED COPY OF INFORMED CONSENT FOR MAIN TRIAL.
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 < 30ml/m.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.TO ASSESS THE HDL CHOLESTEROL RAISING PROPERTY OF VCO. <br/ ><br>2.TO ASSESS THE ANTIOXIDANT PROPERTY OF VCO. <br/ ><br>3.TO ASSESS THE INFLUENCE OF VCO ON Apo B/A RATIO.Timepoint: 1.TO ASSESS THE HDL CHOLESTEROL RAISING PROPERTY OF VCO. <br/ ><br>2.TO ASSESS THE ANTIOXIDANT PROPERTY OF VCO. <br/ ><br>3.TO ASSESS THE INFLUENCE OF VCO ON Apo B/A RATIO. <br/ ><br>TIME POINT ONE FOR SAFETY 1 MONTH. <br/ ><br>3RD AND 6TH MONTH PRIMARY AND SECONDARY OUTCOME.
- Secondary Outcome Measures
Name Time Method To assess the effect of virgin coconut oils on Diabetes and inflammatory markers. <br/ ><br>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. <br/ ><br>Timepoint: At baseline,1month [safety],3 month and 6 months