Effects of Plant Stanol Esters on Blood Flow

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: plant stanol ester

• Registration Number: NCT01315964
• Lead Sponsor: University of Helsinki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Primary Completion: 2011-12
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plant stanol ester	plant stanol ester	3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months
Placebo	plant stanol ester	a margarine product as part of daily diet, which is not containing plant stanol esters

Primary Outcome Measures

Name	Time	Method
Structure and function of the arterial wall	6 months

Secondary Outcome Measures

Name	Time	Method
serum composition of fats	6 months

Trial Locations

Locations (1)

Biomedicum Helsinki; 🇫🇮 Helsinki, Finland