HypercholesterolemiaNCT00738933
Dietary Phytosterols and Human Aortic Valve
A study testing Dietary plant stanols and Dietary plant sterols in people with Hypercholesterolemia and Atherosclerosis, run by University of Helsinki at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Atherosclerosis
- What is being tested?
- Dietary plant stanols and Dietary plant sterols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atherosclerotic aortic valve disease needing an aortic valve replacement operation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Department of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital (HUCH)
Helsinki, 00029HUS
Markku Nissinen, MD, PhD, +358 9 4711, markku.nissinen@hus.fi
Tatu A Miettinen, Professor
About this study
Official title: Effects of Dietary Plant Sterols and Stanols on Sterol Composition and Structure of the Human Aortic Valve
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.
Read the 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.
- Conditions
- Hypercholesterolemia, Atherosclerosis
- Being tested
- Dietary plant stanols, Dietary plant sterols, placebo
- Keywords
- Atherosclerosis, Plant sterols, Plant stanols, Aortic valve
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary plant stanolsDietary supplement
Daily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation
Dietary plant sterolsDietary supplement
Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation
placeboDietary supplement
Margarine product without plant stanol or sterol esters
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | A group of patients consuming 2 grams plant stanols 4-8 weeks before the operation Receives: Dietary Supplement: Dietary plant stanols |
| E | Active comparator | A group of patients consuming daily 2 grams plant sterols 4-8 weeks before the operation. Receives: Dietary Supplement: Dietary plant sterols |
| C | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of serum and aortic valve sterols at the time of aortic valve operation
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Investigators
- Tatu A. Miettinen, professor, Principal investigator, Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum HelsinkiHelena Gylling, Professor, Principal investigator, Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, FinlandMarkku J Nissinen, MD, PhD, Principal investigator, Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738933
- Sponsor's protocol ID
- 231857
- Status last verified
- Feb 2011
- First submitted
- 20 Aug 2008
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25857271Simonen 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.
PubMed 25614126
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Plant Sterols and Stanols on Sterol Composition and Structure of the Human Aortic Valve
- ClinicalTrials.gov ID
- NCT00738933
- Acronym / sponsor ID
- 231857
- Conditions
- Hypercholesterolemia, Atherosclerosis
- Keywords
- Atherosclerosis, Plant sterols, Plant stanols, Aortic valve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Apr 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Dietary Supplement: Dietary plant stanolsA group of patients consuming 2 grams plant stanols 4-8 weeks before the operation |
| E | Active comparator | Dietary Supplement: Dietary plant sterolsA group of patients consuming daily 2 grams plant sterols 4-8 weeks before the operation. |
| C | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Atherosclerotic aortic valve disease needing an aortic valve replacement operation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary plant stanolsDaily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation | Dietary supplement | A |
| Dietary plant sterolsDaily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation | Dietary supplement | E |
| placeboMargarine product without plant stanol or sterol esters | Dietary supplement | C |
Primary outcome
Composition of serum and aortic valve sterols at the time of aortic valve operation
Time frame: Up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
- Derived from this study: PubMed 25857271Simonen 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.
- Derived from this study: PubMed 25614126Simonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatu A. Miettinen, professor principal investigator
Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki
Helena Gylling, Professor principal investigator
Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland
Markku J Nissinen, MD, PhD principal investigator
Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary plant stanols and Dietary plant sterols in people with Hypercholesterolemia and Atherosclerosis, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markku J. Nissinen, MD, PhD (+358 9 4711, markku.nissinen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of serum and aortic valve sterols at the time of aortic valve operation (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738933, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2011; AzTrials last refreshed its copy on 31 Oct 2026.