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
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-
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Uppsala, Sweden, S-751 83
- KPL Good Food Practice AB
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-
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
|
4 weeks intervention, 3 times daily
|
|
Active Comparator: Dose 2
Spread that contains plant sterols and fish oil
|
4 weeks intervention, 3 times daily
|
|
Active Comparator: Dose 3
Spread that contains plant sterols and fish oil
|
4 weeks intervention, 3 times daily
|
|
Placebo Comparator: Placebo
Placebo spread
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4 weeks, 3 times daily
|
|
Active Comparator: Control
Spread that contains 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
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.
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
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.