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Effects of Plant Stanol Esters on Blood Flow

Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01315964
Acronym
BLOOD FLOW
Enrollment
100
Registered
2011-03-16
Start date
2011-02-28
Completion date
2013-08-31
Last updated
2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

cholesterol, plant sterols, atherosclerosis, arterial stiffness

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.

Interventions

DIETARY_SUPPLEMENTplant 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

Sponsors

Finnish Institute of Occupational Health
CollaboratorOTHER
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Structure and function of the arterial wall6 months

Secondary

MeasureTime frame
serum composition of fats6 months

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026