The Effects of a Spread With Added Plant Sterols and Omega-3 Fatty Acids on Blood Lipids

Study Overview
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Brief Summary
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The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations. The study also aims to investigate the effect of plant sterols and fish oil on fasting total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C) and non-HDL-C. At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored.

Detailed Description
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The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting TG concentrations. The study also aims to investigate the effect of plant sterols and fish oil on fasting TC, LDL-C, HDL-C and non-HDL-C. At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored. This exploratory objective will only be analyzed if a relevant treatment effect on fasting triglycerides concentrations is observed.

Official Title
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The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids

Conditions
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Vascular Diseases, Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Margarine enriched with plant sterols and fish oil
* Dietary Supplement: Placebo margarine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting TG levels at screening: ≥ 1.40 and ≤ 5.60 mmol/L Fasting LDL-C levels at screening: ≥ 3.4 and ≤ 4.9 mmol/L Exclusion Criteria: Recently (<6 months) diagnosed with cardiovascular event(s), revascularization or systemic inflammatory conditions. Medical history which might impact study measurements, to be judged by the study physician Use of over-the-counter and prescribed medication which may interfere with study measurements Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening. Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Margarine enriched with plant sterols and fish oil<br>Low-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil | Dietary Supplement: Margarine enriched with plant sterols and fish oil<br> <br> |
| Placebo Comparator: Placebo margarine<br>Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA | Dietary Supplement: Placebo margarine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TG concentrations | Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29) | At baseline (after 2 weeks run-in period) and after 4 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood lipids | Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29) | At baseline (after 2 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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Plant sterols, Fish oil, Blood lipids