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

University of Helsinki

Status: Completed

Conditions: Atherosclerosis

Treatments: Dietary Supplement: plant stanol ester

Study type: Interventional

Funder types: Other

Identifiers

NCT01315964

3352

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

plant stanol ester

Active Comparator group

Description:

3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months

Treatment:

Dietary Supplement: plant stanol ester

Placebo

Placebo Comparator group

Description:

a margarine product as part of daily diet, which is not containing plant stanol esters

Treatment:

Dietary Supplement: plant stanol ester