Effect of Omega -3 Fatty Acids Supplements and Plant Sterol Enriched Food in Dyslipidemic Adults

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Male

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 important risk factors for CVD. There is a strong body of evidence for the beneficial effects of plant sterols on blood total and LDL-cholesterol and omega-3 fatty acids from fish on blood triglycerides. However, the combined benefits of consuming both plant sterols and omega-3 fatty acids from fish oil on blood cholesterol and triglycerides has not been investigated previously, except in one study where the methodology used was not the most appropriate for testing such a combination. In addition, most studies on plant sterol efficacy realised so far were done in Western countries. The present study will investigate the efficacy of plant sterols and omega-3 fatty acids from fish oil on improving the cardiovascular risk profile of Indian adults with dyslipidemia.

It is expected that, after 4 weeks of intervention, men consuming both plant sterols and omega-3 fatty acids from fish oil will have a lower cardiovascular risk profile than men receiving only plant sterols or only fish oil or none of these dietary supplements.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre for Chronic Disease Control, India

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.