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

This study has been completed.
Sponsor:
Collaborator:
Finnish Institute of Occupational Health
Information provided by (Responsible Party):
Markku Nissinen, Helsinki University
ClinicalTrials.gov Identifier:
NCT01315964
First received: March 15, 2011
Last updated: August 27, 2013
Last verified: August 2013

March 15, 2011
August 27, 2013
February 2011
December 2011   (final data collection date for primary outcome measure)
Structure and function of the arterial wall [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01315964 on ClinicalTrials.gov Archive Site
serum composition of fats [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Plant Stanol Esters on Blood Flow
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Atherosclerosis
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
  • 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
    Intervention: Dietary Supplement: plant stanol ester
  • Placebo Comparator: Placebo
    a margarine product as part of daily diet, which is not containing plant stanol esters
    Intervention: Dietary Supplement: plant stanol ester
Gylling H, Halonen J, Lindholm H, Konttinen J, Simonen P, Nissinen MJ, Savolainen A, Talvi A, Hallikainen M. The effects of plant stanol ester consumption on arterial stiffness and endothelial function in adults: a randomised controlled clinical trial. BMC Cardiovasc Disord. 2013 Jul 10;13:50. doi: 10.1186/1471-2261-13-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2013
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01315964
3352
No
Markku Nissinen, Helsinki University
Helsinki University
Finnish Institute of Occupational Health
Study Director: Markku J Nissinen, MD Docent Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital
Helsinki University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP