Clinical trial NCT01315964: Effects of Plant Stanol Esters on Blood Flow
Official title: Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: cholesterol
plant sterols
atherosclerosis
arterial stiffness
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Finnish Institute of Occupational Health
First posted: 2011-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* healthy human subjects

Exclusion Criteria:

* abnormal liver, kidney and thyroid function
* unstable myocardial disease
* inflammatory bowel disease
* alcohol abuse
* pregnancy
* any lipid-lowering medication

Primary outcomes:
measure: Structure and function of the arterial wall
timeFrame: 6 months
Secondary outcomes:
measure: serum composition of fats
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Biomedicum Helsinki
Study officials:
affiliation: Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital
name: Markku J Nissinen, MD Docent
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.