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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Active Comparator | Spread that contains plant sterols and fish oil |
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| Dose 2 | Active Comparator | Spread that contains plant sterols and fish oil |
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| Dose 3 | Active Comparator | Spread that contains plant sterols and fish oil |
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| Placebo | Placebo Comparator | Placebo spread |
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| Control | Active Comparator | Spread that contains plant sterols |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant sterols and fish oil | Dietary Supplement | 4 weeks intervention, 3 times daily |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Olsson, PhD | KPL Good Food Practice AB | Principal Investigator |
| Birgitta Sundberg, PhD | KPL Good Food Practice AB | Study Director |
| Anneli Hallmin | KPL Good Food Practice AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KPL Good Food Practice AB | Uppsala | S-751 83 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25122648 | Derived | 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. |
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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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| Plant sterols | Dietary Supplement | 4 weeks intervention, 3 times daily |
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| Placebo | Dietary Supplement | 4 weeks, 3 times daily |
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| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |
| D009821 | Oils |