Dietary Phytosterols and Human Aortic Valve

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00738933
• Other study ID #: 231857
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2008
• Last updated: February 11, 2011
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2011
• Source: Helsinki University
• Contact: Markku J. Nissinen, MD, PhD
• Phone: +358 9 4711
• Email: markku.nissinen[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Atherosclerotic aortic valve disease needing an aortic valve replacement operation

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Dietary plant stanols
Daily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation
• Dietary plant sterols
Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation
• placebo
Margarine product without plant stanol or sterol esters

Locations

Country	Name	City	State
Finland	Department of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital (HUCH)	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composition of serum and aortic valve sterols at the time of aortic valve operation		Up to 4 weeks	Yes