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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy, Mildly Elevated Cholesterol Levels

Intervention / Treatment
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* Dietary Supplement: Plant sterols and fish oil
* Dietary Supplement: Plant sterols
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood lipid profile | 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 |  | At baseline (after 4 weeks run-in period) and after 4 weeks intervention | 
| Change in metabolomic parameters | For exploratory purposes | At baseline (after 4 weeks run-in period) and after 4 weeks intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dose-response study, blood lipid profile, plant sterols, fish oil