NCT00738933

Brief Summary

This randomized controlled double-blind intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve. The study patients will include 50-60 voluntary patients from the Helsinki Univ. Central Hospital, who will undergo aortic valve surgery. The patients will be randomized into plant sterol (E), plant stanol (A) and control (C) groups. Patients in the E and A groups will be asked to consume daily 2 grams plant sterols or plant stanols, respectively, in a margarine product.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 14, 2011

Status Verified

February 1, 2011

Enrollment Period

3.7 years

First QC Date

August 20, 2008

Last Update Submit

February 11, 2011

Conditions

HypercholesterolemiaAtherosclerosis

Keywords

AtherosclerosisPlant sterolsPlant stanolsAortic valve

Outcome Measures

Primary Outcomes (1)

  • Composition of serum and aortic valve sterols at the time of aortic valve operation

    Up to 4 weeks

Study Arms (3)

A

ACTIVE COMPARATOR

A group of patients consuming 2 grams plant stanols 4-8 weeks before the operation

Dietary Supplement: Dietary plant stanols

E

ACTIVE COMPARATOR

A group of patients consuming daily 2 grams plant sterols 4-8 weeks before the operation.

Dietary Supplement: Dietary plant sterols

C

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

Dietary plant stanolsDIETARY_SUPPLEMENT

Daily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation

A
Dietary plant sterolsDIETARY_SUPPLEMENT

Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation

E
placeboDIETARY_SUPPLEMENT

Margarine product without plant stanol or sterol esters

C

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atherosclerotic aortic valve disease needing an aortic valve replacement operation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital (HUCH)

Helsinki, 00029HUS, Finland

RECRUITING

Related Publications (2)

  • Simonen P, Stenman UH, Gylling H. Serum proprotein convertase subtilisin/kexin type 9 concentration is not increased by plant stanol ester consumption in normo- to moderately hypercholesterolaemic non-obese subjects. The BLOOD FLOW intervention study. Clin Sci (Lond). 2015 Sep;129(5):439-46. doi: 10.1042/CS20150193. Epub 2015 Apr 10.

    PMID: 25857271DERIVED

  • Simonen P, Lommi J, Hallikainen M, Helske-Suihko S, Werkkala K, Kupari M, Kovanen PT, Gylling H. Dietary plant stanols or sterols neither accumulate in stenotic aortic valves nor influence their structure or inflammatory status. Clin Nutr. 2015 Dec;34(6):1251-7. doi: 10.1016/j.clnu.2015.01.001. Epub 2015 Jan 7.

    PMID: 25614126DERIVED

MeSH Terms

Conditions

HypercholesterolemiaAtherosclerosis

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tatu A. Miettinen, professor

    Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki

    PRINCIPAL INVESTIGATOR

  • Helena Gylling, Professor

    Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland

    PRINCIPAL INVESTIGATOR

  • Markku J Nissinen, MD, PhD

    Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Markku J. Nissinen, MD, PhD

CONTACT

+358 9 4711markku.nissinen@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 14, 2011

Record last verified: 2011-02

Locations

FI(1)