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

August 27, 2013 updated by: Markku Nissinen, University of Helsinki

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Biomedicum Helsinki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Benecol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Structure and function of the arterial wall
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
serum composition of fats
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Finnish Institute of Occupational Health

Investigators

  • Study Director: Markku J Nissinen, MD Docent, Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 15, 2011

First Submitted That Met QC Criteria

March 15, 2011

First Posted (Estimate)

March 16, 2011

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3352

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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