Trial | NCT01315964  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    plant stanol ...

  • Study Participants

    100
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.
Study Started
Feb 28
2011
Primary Completion
Dec 31
2011
Study Completion
Aug 31
2013
Last Update
Aug 28
2013
Estimate

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 names: Benecol

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

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
No Results Posted