NCT01315964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

10 months

First QC Date

March 15, 2011

Last Update Submit

August 27, 2013

Conditions

Atherosclerosis

Keywords

cholesterolplant sterolsatherosclerosisarterial stiffness

Outcome Measures

Primary Outcomes (1)

  • Structure and function of the arterial wall

    6 months

Secondary Outcomes (1)

  • serum composition of fats

    6 months

Study Arms (2)

plant stanol ester

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: plant stanol ester

Interventions

plant stanol esterDIETARY_SUPPLEMENT

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

Also known as: Benecol
Placeboplant stanol ester

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy human subjects

You may not qualify if:

  • abnormal liver, kidney and thyroid function
  • unstable myocardial disease
  • inflammatory bowel disease
  • alcohol abuse
  • pregnancy
  • any lipid-lowering medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedicum Helsinki

Helsinki, 00029, Finland

Location

Related Publications (3)

  • 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.

    PMID: 32611242DERIVED

  • 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.

    PMID: 24499098DERIVED

  • 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.

    PMID: 23841572DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

plant stanol ester

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Markku J Nissinen, MD Docent

    Dept. of Medicine, Div. of Gastroenterology, Helsinki Univ. Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

August 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

FI(1)