Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil

February 5, 2012 updated by: Unilever R&D

Efficacy Study on the Lipid-lowering Effect of a Spread Enriched With the Recommended Dose of Plant Sterols and 3 Different Doses of Fatty Acids From Fish Oil

Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, S-751 83
        • KPL Good Food Practice AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Apparently healthy men and women
  • Age ≥ 25 and ≤ 75 years old
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
  • Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
  • 10-year CVD risk equal or lower than 10% according to "SCORE"
  • Blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges
  • Informed consent and biobank consent signed
  • Willing to comply to study protocol during study
  • Agreeing to be informed about medically relevant personal test-results by a physician
  • Not smoking
  • Accessible veins on the forearm
  • Habitually consuming spreads

Exclusion Criteria:

  • Pregnant or having the wish to become pregnant, or lactating
  • Use of prescribed medication which may interfere with study measurements
  • Use of antibiotics in the 3 months before screening or during the study
  • Use of any medically- or self-prescribed diet with the purpose to reduce weight
  • Intolerance for gluten or lactose
  • Reported food allergy
  • Having bleeding disorders
  • Recent blood donation
  • Excessive alcohol consumption
  • Strenuous exercise
  • Reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs
  • Recent participation in another nutritional or medical trial
  • Participation in night shift work

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dose 1
Spread that contains plant sterols and fish oil
Dietary supplement: Plant sterols and fish oil
4 weeks intervention, 3 times daily
Active Comparator: Dose 2
Spread that contains plant sterols and fish oil
Dietary supplement: Plant sterols and fish oil
4 weeks intervention, 3 times daily
Active Comparator: Dose 3
Spread that contains plant sterols and fish oil
Dietary supplement: Plant sterols and fish oil
4 weeks intervention, 3 times daily
Placebo Comparator: Placebo
Placebo spread
Dietary supplement: Placebo
4 weeks, 3 times daily
Active Comparator: Control
Spread that contains plant sterols
Dietary supplement: Plant sterols
4 weeks intervention, 3 times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood lipid profile
Time Frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
At baseline (after 4 weeks run-in period) and after 4 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in EPA/DHA in red blood cells
Time Frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Change in metabolomic parameters
Time Frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention
For exploratory purposes
At baseline (after 4 weeks run-in period) and after 4 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unilever R&D

Investigators

  • Principal Investigator: Johan Olsson, PhD, KPL Good Food Practice AB
  • Study Director: Birgitta Sundberg, PhD, KPL Good Food Practice AB
  • Study Director: Anneli Hallmin, KPL Good Food Practice AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 5, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10018V

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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