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Effects of Plant Stanol Esters on Blood Flow (BLOOD FLOW)

This study has been completed.
Finnish Institute of Occupational Health
Information provided by (Responsible Party):
Markku Nissinen, Helsinki University Identifier:
First received: March 15, 2011
Last updated: August 27, 2013
Last verified: August 2013

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.

Condition Intervention
Dietary Supplement: plant stanol ester

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study

Resource links provided by NLM:

Further study details as provided by Markku Nissinen, Helsinki University:

Primary Outcome Measures:
  • Structure and function of the arterial wall [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • serum composition of fats [ Time Frame: 6 months ]

Enrollment: 100
Study Start Date: February 2011
Study Completion Date: August 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: plant stanol ester
3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months
Dietary Supplement: 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 Name: Benecol
Placebo Comparator: Placebo
a margarine product as part of daily diet, which is not containing plant stanol esters
Dietary Supplement: 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 Name: Benecol


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT01315964

Biomedicum Helsinki
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University
Finnish Institute of Occupational Health
Study Director: Markku J Nissinen, MD Docent Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Markku Nissinen, MD PhD, Helsinki University Identifier: NCT01315964     History of Changes
Other Study ID Numbers: 3352
Study First Received: March 15, 2011
Last Updated: August 27, 2013

Keywords provided by Markku Nissinen, Helsinki University:
plant sterols
arterial stiffness

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on May 25, 2017