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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Helsinki University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Finnish Institute of Occupational Health
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT01315964
First received: March 15, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Atherosclerosis
 Dietary Supplement: plant stanol ester

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Structure and function of the arterial wall [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • serum composition of fats [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Benecol

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315964

Contacts
Contact: Helena Gylling, Professor +358 0 471 71850 helena.gylling@hus.fi
Contact: Markku J. Nissinen, Docent +358 0 471 71850 markku.nissinen@hus.fi

Locations
Finland
Biomedicum Helsinki Recruiting
Helsinki, Finland, 00029
Contact: Leena Kaipiainen, Study Nurse     +358 0 471 71850     leena.kaipiainen@hus.fi    
Principal Investigator: Helena Gylling, Professor            
Sub-Investigator: Markku Nissinen, Docent            
Sponsors and Collaborators
Helsinki University
Finnish Institute of Occupational Health
Investigators
Study Director: Markku J Nissinen, MD Docent Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital
  More Information

No publications provided

Responsible Party: Markku Nissinen, Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital
ClinicalTrials.gov Identifier: NCT01315964     History of Changes
Other Study ID Numbers: 3352
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University:
cholesterol
plant sterols
atherosclerosis
arterial stiffness

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013