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

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
plant stanol ester
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atherosclerosis focused on measuring cholesterol, plant sterols, atherosclerosis, arterial stiffness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Biomedicum Helsinki

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

plant stanol ester

Placebo

Arm Description

3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months

a margarine product as part of daily diet, which is not containing plant stanol esters

Outcomes

Primary Outcome Measures

Structure and function of the arterial wall

Secondary Outcome Measures

serum composition of fats

Full Information

First Posted
March 15, 2011
Last Updated
August 27, 2013
Sponsor
University of Helsinki
Collaborators
Finnish Institute of Occupational Health
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1. Study Identification

Unique Protocol Identification Number
NCT01315964
Brief Title
Effects of Plant Stanol Esters on Blood Flow
Acronym
BLOOD FLOW
Official Title
Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Finnish Institute of Occupational Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
cholesterol, plant sterols, atherosclerosis, arterial stiffness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plant stanol ester
Arm Type
Active Comparator
Arm Description
3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
a margarine product as part of daily diet, which is not containing plant stanol esters
Intervention Type
Dietary Supplement
Intervention Name(s)
plant stanol ester
Other Intervention Name(s)
Benecol
Intervention Description
3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months
Primary Outcome Measure Information:
Title
Structure and function of the arterial wall
Time Frame
6 months
Secondary Outcome Measure Information:
Title
serum composition of fats
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku J Nissinen, MD Docent
Organizational Affiliation
Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Biomedicum Helsinki
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32611242
Citation
Ruuth M, Aikas L, Tigistu-Sahle F, Kakela R, Lindholm H, Simonen P, Kovanen PT, Gylling H, Oorni K. Plant Stanol Esters Reduce LDL (Low-Density Lipoprotein) Aggregation by Altering LDL Surface Lipids: The BLOOD FLOW Randomized Intervention Study. Arterioscler Thromb Vasc Biol. 2020 Sep;40(9):2310-2321. doi: 10.1161/ATVBAHA.120.314329. Epub 2020 Jul 2.
Results Reference
derived
PubMed Identifier
24499098
Citation
Hallikainen M, Halonen J, Konttinen J, Lindholm H, Simonen P, Nissinen MJ, Gylling H. Diet and cardiovascular health in asymptomatic normo- and mildly-to-moderately hypercholesterolemic participants - baseline data from the BLOOD FLOW intervention study. Nutr Metab (Lond). 2013 Oct 7;10(1):62. doi: 10.1186/1743-7075-10-62.
Results Reference
derived
PubMed Identifier
23841572
Citation
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.
Results Reference
derived

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Effects of Plant Stanol Esters on Blood Flow

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