Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil
NCT ID: NCT01313988
Last Updated: 2012-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
332 participants
INTERVENTIONAL
2011-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose 1
Spread that contains plant sterols and fish oil
Plant sterols and fish oil
4 weeks intervention, 3 times daily
Dose 2
Spread that contains plant sterols and fish oil
Plant sterols and fish oil
4 weeks intervention, 3 times daily
Dose 3
Spread that contains plant sterols and fish oil
Plant sterols and fish oil
4 weeks intervention, 3 times daily
Placebo
Placebo spread
Placebo
4 weeks, 3 times daily
Control
Spread that contains plant sterols
Plant sterols
4 weeks intervention, 3 times daily
Interventions
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Plant sterols and fish oil
4 weeks intervention, 3 times daily
Plant sterols
4 weeks intervention, 3 times daily
Placebo
4 weeks, 3 times daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
75 Years
ALL
Yes
Sponsors
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Unilever R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Johan Olsson, PhD
Role: PRINCIPAL_INVESTIGATOR
KPL Good Food Practice AB
Birgitta Sundberg, PhD
Role: STUDY_DIRECTOR
KPL Good Food Practice AB
Anneli Hallmin
Role: STUDY_DIRECTOR
KPL Good Food Practice AB
Locations
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KPL Good Food Practice AB
Uppsala, , Sweden
Countries
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References
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Ras RT, Demonty I, Zebregs YE, Quadt JF, Olsson J, Trautwein EA. Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women. J Nutr. 2014 Oct;144(10):1564-70. doi: 10.3945/jn.114.192229. Epub 2014 Aug 13.
Other Identifiers
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10018V
Identifier Type: -
Identifier Source: org_study_id
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