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Dietary Phytosterols and Human Aortic Valve

Primary Purpose

Hypercholesterolemia, Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Dietary plant stanols
Dietary plant sterols
placebo
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Atherosclerosis, Plant sterols, Plant stanols, Aortic valve

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Atherosclerotic aortic valve disease needing an aortic valve replacement operation

Exclusion Criteria:

  • None

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

A

E

C

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2008
Last Updated
February 11, 2011
Sponsor
University of Helsinki
Collaborators
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT00738933
Brief Title
Dietary Phytosterols and Human Aortic Valve
Official Title
Effects of Dietary Plant Sterols and Stanols on Sterol Composition and Structure of the Human Aortic Valve
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Helsinki
Collaborators
University of Eastern Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Atherosclerosis
Keywords
Atherosclerosis, Plant sterols, Plant stanols, Aortic valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
A group of patients consuming 2 grams plant stanols 4-8 weeks before the operation
Arm Title
E
Arm Type
Active Comparator
Arm Description
A group of patients consuming daily 2 grams plant sterols 4-8 weeks before the operation.
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary plant stanols
Intervention Description
Daily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary plant sterols
Intervention Description
Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
Margarine product without plant stanol or sterol esters
Primary Outcome Measure Information:
Title
Composition of serum and aortic valve sterols at the time of aortic valve operation
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Atherosclerotic aortic valve disease needing an aortic valve replacement operation Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markku J. Nissinen, MD, PhD
Phone
+358 9 4711
Email
markku.nissinen@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatu A. Miettinen, professor
Organizational Affiliation
Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helena Gylling, Professor
Organizational Affiliation
Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markku J Nissinen, MD, PhD
Organizational Affiliation
Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital (HUCH)
City
Helsinki
ZIP/Postal Code
00029HUS
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markku Nissinen, MD, PhD
Phone
+358 9 4711
Email
markku.nissinen@hus.fi
First Name & Middle Initial & Last Name & Degree
Tatu A Miettinen, Professor
First Name & Middle Initial & Last Name & Degree
Markku J Nissinen, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25857271
Citation
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.
Results Reference
derived
PubMed Identifier
25614126
Citation
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.
Results Reference
derived

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Dietary Phytosterols and Human Aortic Valve

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