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
  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:


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 ]

Enrollment: 100
Study Start Date: February 2011
Study Completion Date: August 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315964

Locations
Finland
Biomedicum Helsinki
Helsinki, Finland, 00029
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 by Helsinki University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Markku Nissinen, MD PhD, Helsinki University
ClinicalTrials.gov Identifier: NCT01315964     History of Changes
Other Study ID Numbers: 3352
Study First Received: March 15, 2011
Last Updated: August 27, 2013
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 July 29, 2014