Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2011-02-28
2013-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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plant stanol ester
3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months
plant stanol ester
3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months
Placebo
a margarine product as part of daily diet, which is not containing plant stanol esters
plant stanol ester
3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months
Interventions
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plant stanol ester
3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* unstable myocardial disease
* inflammatory bowel disease
* alcohol abuse
* pregnancy
* any lipid-lowering medication
18 Years
70 Years
ALL
Yes
Sponsors
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Finnish Institute of Occupational Health
OTHER
University of Helsinki
OTHER
Responsible Party
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Markku Nissinen
MD PhD
Principal Investigators
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Markku J Nissinen, MD Docent
Role: STUDY_DIRECTOR
Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital
Locations
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Biomedicum Helsinki
Helsinki, , Finland
Countries
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References
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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.
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.
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.
Other Identifiers
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3352
Identifier Type: -
Identifier Source: org_study_id