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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Margarine enriched with plant sterols and fish oil | Active Comparator | Low-fat margarine (25 g per day) with added plant sterols and Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) from fish oil |
|
| Placebo margarine | Placebo Comparator | Low-fat margarine (25 g per day) without added plant sterols and EPA + DHA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Margarine enriched with plant sterols and fish oil | Dietary Supplement |
| ||
| Placebo margarine |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in apolipoprotein concentrations | Samples will only be analyzed if relevant treatment effects on TG are observed | At baseline (after 2 weeks run-in period) and after 4 weeks intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wieneke Koppenol, MSc | Unilever R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite Research Organisation | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29725824 | Derived | Blom WAM, Koppenol WP, Hiemstra H, Stojakovic T, Scharnagl H, Trautwein EA. A low-fat spread with added plant sterols and fish omega-3 fatty acids lowers serum triglyceride and LDL-cholesterol concentrations in individuals with modest hypercholesterolaemia and hypertriglyceridaemia. Eur J Nutr. 2019 Jun;58(4):1615-1624. doi: 10.1007/s00394-018-1706-1. Epub 2018 May 3. |
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D010840 | Phytosterols |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Dietary Supplement |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |
| D009821 | Oils |