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

NCT00422266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2007-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Omega 3 fatty acids and plant sterol enriched drink

DIETARY_SUPPLEMENT

Omega 3 fatty acids and plant sterols

Capsules and Yoghurt based minidrink

Sponsors & Collaborators

  • Centre for Chronic Disease Control, India

    lead OTHER

Principal Investigators

  • Srinath Reddy, MD, DM, MSc, · Centre for Chronic Disease Control, India

  • Prabhakaran Dorairaj, MD, DM, MSc · Centre for Chronic Disease Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Completion
2007-03-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422266 on ClinicalTrials.gov