Effects of Plant Stanol Esters on Blood Flow

Atherosclerosis Clinical Trial

— BLOOD FLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315964
• Other study ID #: 3352
• Status: Completed
• Phase: N/A
• First received: March 15, 2011
• Last updated: August 27, 2013
• Start date: February 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

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

Locations

Country	Name	City	State
Finland	Biomedicum Helsinki	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Finnish Institute of Occupational Health

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structure and function of the arterial wall		6 months	Yes
Secondary	serum composition of fats		6 months	Yes