Status:
COMPLETED
Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Food in Dyslipidemic Adults
Lead Sponsor:
Centre for Chronic Disease Control, India
Conditions:
Dyslipidemia
Eligibility:
MALE
35-55 years
Phase:
PHASE3
Brief Summary
The incidence of chronic degenerative diseases, especially cardiovascular disease (CVD), is high world over and especially in India. High blood cholesterol and triglyceride levels are known to be impo...
Detailed Description
This study has a double-blind, placebo-controlled, randomized parallel (2 x 2 factorial) design with 3 experimental treatments and one control treatment. A two week run-in period will be observed duri...
Eligibility Criteria
Inclusion
- Male subjects aged between 35-55 years.
- Total cholesterol (TC) between 5.0 - 8.0 mmol/L.
- Body Mass Index (BMI) is between 18-30 kg/m2.
- Willing to consume the intervention product.
- Willing to participate in the study and perform all measurements including. blood drawing, anthropometry, dietary assessment and questionnaires.
- Informed consent signed by subject.
Exclusion
- Smokers (more than 10 cigarettes per day).
- Heavy drinker (more than 6 large pegs or 360 ml of 40% alcohol per week).
- Triglycerides \> 4.0 mmol/L.
- Individuals with chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke, diabetes, chronic renal failure, gastrointestinal disease, metabolic diseases (eg. thyroid, pancreas) and people with a compromised GI function like after extensive bowel resections.
- Fasting blood glucose \> 120mg/dl and glycosylated hemoglobin \> 7.5%.
- Individuals on medication (e.g.: insulin, oral hypoglycemic drugs, beta blockers, steroids or lipid-lowering drugs) or dietary supplements known to alter lipid and/or glucose metabolism during the study, including plant sterol-enriched foods and fish oil supplements, or having used these substances in 3 months preceding the intervention period.
- Reported participation in another biomedical trial 3 months before the start of the study or during the study.
- Reported weight loss / gain (10% or more) during the last 6 months.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00422266
Start Date
December 1 2006
End Date
March 1 2007
Last Update
September 26 2007
Active Locations (1)
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1
National Thermal Power Corporation
Delhi, Badarpur, India