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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.

Not Applicable
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 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 <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

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
NameTimeMethod
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
NameTimeMethod
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
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