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

NCT00422266 | Completed Phase 3 DMC

• 1 other identifier: CCDC-6980
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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 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

Dyslipidemia

Keywords

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Changes in TC, LDL-C, HDL-C, Triglycerides, and Fasting blood glucose.

Secondary Outcomes (1)

• Changes in LDL particle size, apo B, CRP and fibrinogen.

Interventions

Omega 3 fatty acids and plant sterol enriched drink DRUG

Omega 3 fatty acids and plant sterols DIETARY_SUPPLEMENT

Capsules and Yoghurt based minidrink

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Chronic Disease Control, India: lead

Study Sites (1)

National Thermal Power Corporation

Delhi, Badarpur, India

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Fatty Acids, Omega-3; Phytosterols

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Phytochemicals; Biological Factors

Study Officials

• Srinath Reddy, MD, DM, MSc,

  Centre for Chronic Disease Control, India

  PRINCIPAL INVESTIGATOR

• Prabhakaran Dorairaj, MD, DM, MSc

  Centre for Chronic Disease Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 15, 2007
• Study Start: December 1, 2006
• Study Completion: March 1, 2007
• Last Updated: September 26, 2007

Record last verified: 2007-09

Locations

IN (1)