Dietary Phytosterols and Human Aortic Valve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques

NCT00737919

Atherosclerosis

COMPLETED NA

Concentration of Plant Sterols in Serum and Aortic Valve Cusps

NCT00222950

Aortic Valve Stenosis

UNKNOWN

Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)

NCT06481020

Cardiovascular Diseases Hypercholesterolemia Prediabetic State +1 more

RECRUITING NA

The Effect of Plant Sterols on Vascular Function

NCT01803178

Vascular Diseases Hypercholesterolemia

COMPLETED NA

The Effect of Plant Sterol Supplement on Blood Cholesterol

NCT00485095

High Blood Cholesterol Level

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.