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Dietary Phytosterols and Human Aortic Valve

Effects of Dietary Plant Sterols and Stanols on Sterol Composition and Structure of the Human Aortic Valve

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00738933
Enrollment
60
Registered
2008-08-21
Start date
2008-04-30
Completion date
2011-12-31
Last updated
2011-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Hypercholesterolemia

Keywords

Atherosclerosis, Plant sterols, Plant stanols, Aortic valve

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.

Detailed description

High level of serum cholesterol is a risk factor for atherosclerotic complications, including atherosclerotic aortic valve disease. Over 50 years dietary plant sterols have been used to inhibit intestinal cholesterol absorption and to decrease its levels in serum. Daily human diet contains numerous different plant sterols, of which sitosterol and campesterol are the most abundant ones. Few epidemiologic studies suggest that sitosterol and campesterol may also be involved in formation of atherosclerotic changes in human arteries. The saturated forms of sitosterol and campesterol, i.e., the plant stanols (mainly sitostanol and campestanol) are beneficial with this respect. As part of daily diet, the plant stanols decrease absorption of both cholesterol and plant sterols, and thus, are putatively even more effective in prevention of atherosclerosis than the respective plant sterols. Our double-blind controlled intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve. 50-60 patients, who will undergo aortic valve surgery, will be asked to volunteer our study. The patients will be randomized into three groups: (A) a group consuming margarine containing daily 2 grams plant stanols, (E) a group consuming margarine containing daily 2 grams of plant sterols, (C) a control group consuming margarine without any plant sterols or stanols. The dietary intervention will last for 4 to 8 weeks from the randomization to the operation. Serum samples for analyses of serum lipids, lipoproteins and sterols will be collected at the randomization and at the operation. The atherosclerotic aortic valve will be examined with respect to its composition of cholesterol, other sterols and stanols. The aim of our study is to elucidate the effects of dietary consumption of plant sterols and stanols on the sterol composition and structure of the atherosclerotic disease-affected aortic valve in human patients.

Interventions

DIETARY_SUPPLEMENTDietary plant stanols

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

DIETARY_SUPPLEMENTDietary plant sterols

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

DIETARY_SUPPLEMENTplacebo

Margarine product without plant stanol or sterol esters

Sponsors

University of Eastern Finland
CollaboratorOTHER
University of Helsinki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Atherosclerotic aortic valve disease needing an aortic valve replacement operation

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Composition of serum and aortic valve sterols at the time of aortic valve operationUp to 4 weeks

Countries

Finland

Contacts

Primary ContactMarkku J. Nissinen, MD, PhD
markku.nissinen@hus.fi+358 9 4711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026