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| Name | Class |
|---|---|
| Finnish Institute of Occupational Health | OTHER |
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Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to 10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s complications (e.g., acute myocardial infarction) in adult human subjects.
The purpose of the present study is to evaluate among healthy human subjects (N=100) effects of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries, arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat® and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary habits are fulfilled. Dietary records (twice for a 3-day-period) are done.
Hypothesis of the study is that a dietary serum cholesterol lowering intervention has beneficial influence on the early prognostic markers of premature atherosclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plant stanol ester | Active Comparator | 3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months |
|
| Placebo | Placebo Comparator | a margarine product as part of daily diet, which is not containing plant stanol esters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plant stanol ester | Dietary Supplement | 3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Structure and function of the arterial wall | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum composition of fats | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markku J Nissinen, MD Docent | Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedicum Helsinki | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41927512 | Derived | Oorni K, Aikas L, Ruuth M, Tigistu-Sahle F, Kakela R, Wester I, Gylling H, Simonen P. High cholesterol absorption efficiency enhances proatherogenic properties of low-density lipoprotein particles. J Intern Med. 2026 Jun;299(6):711-725. doi: 10.1111/joim.70085. Epub 2026 Apr 2. | |
| 32611242 | Derived | Ruuth M, Aikas L, Tigistu-Sahle F, Kakela R, Lindholm H, Simonen P, Kovanen PT, Gylling H, Oorni K. Plant Stanol Esters Reduce LDL (Low-Density Lipoprotein) Aggregation by Altering LDL Surface Lipids: The BLOOD FLOW Randomized Intervention Study. Arterioscler Thromb Vasc Biol. 2020 Sep;40(9):2310-2321. doi: 10.1161/ATVBAHA.120.314329. Epub 2020 Jul 2. |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C407042 | plant stanol ester |
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| 24499098 | Derived | Hallikainen M, Halonen J, Konttinen J, Lindholm H, Simonen P, Nissinen MJ, Gylling H. Diet and cardiovascular health in asymptomatic normo- and mildly-to-moderately hypercholesterolemic participants - baseline data from the BLOOD FLOW intervention study. Nutr Metab (Lond). 2013 Oct 7;10(1):62. doi: 10.1186/1743-7075-10-62. |
| 23841572 | Derived | Gylling H, Halonen J, Lindholm H, Konttinen J, Simonen P, Nissinen MJ, Savolainen A, Talvi A, Hallikainen M. The effects of plant stanol ester consumption on arterial stiffness and endothelial function in adults: a randomised controlled clinical trial. BMC Cardiovasc Disord. 2013 Jul 10;13:50. doi: 10.1186/1471-2261-13-50. |