AtherosclerosisNCT00737919
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
A study testing Plant Stanol and Plant Sterol in people with Atherosclerosis, run by University of Helsinki at 1 site in Finland.
Trial summary
This study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Plant Stanol and Plant Sterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- May 2006to Dec 2009
- 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
- Asymptomatic tight carotid plaques
- Age 40-80
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Surgery, Div. of Vascular Surgery, Helsinki University Central Hospital
Helsinki, 00029
About this study
This study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques.
Read the detailed description
This is a double-blind randomized study. The study population will consist of 30 consecutive patients who will undergo an elective carotid endarterectomy due to a tight asymptomatic stenosis. The patients will be randomized into two groups consuming either plant sterol (2g/day) or plant stanol (2g/day) spreads for two to six weeks, until the operation. Serum lipids, lipoproteins and sterols will be analyzed at the randomization, before the operation and one month after the operation. The carotid arteries will be examined for their composition of sterols.
This study gives new information concerning the relationship between dietary consumption of plant sterols and stanols and the sterol composition of the carotid plaques.
- Conditions
- Atherosclerosis
- Being tested
- Plant Stanol, Plant Sterol
- Keywords
- Cholesterol, Plant sterols, Atherosclerotic carotid plaques
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant StanolDietary supplement
Plant stanols in margarines daily 2 grams
Plant SterolDietary supplement
Plant sterols in margarines daily 2 grams
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation Receives: Dietary Supplement: Plant Stanol |
| 2 | Active comparator | A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation Receives: Dietary Supplement: Plant Sterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sterols in serum and carotid plaques at the operation
Measured: at operation and one month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT00737919
- Sponsor's protocol ID
- 215953
- Status last verified
- Aug 2008
- First submitted
- 19 Aug 2008
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques
- ClinicalTrials.gov ID
- NCT00737919
- Acronym / sponsor ID
- 215953
- Conditions
- Atherosclerosis
- Keywords
- Cholesterol, Plant sterols, Atherosclerotic carotid plaques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- May 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 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 study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques.
Detailed description
This is a double-blind randomized study. The study population will consist of 30 consecutive patients who will undergo an elective carotid endarterectomy due to a tight asymptomatic stenosis. The patients will be randomized into two groups consuming either plant sterol (2g/day) or plant stanol (2g/day) spreads for two to six weeks, until the operation. Serum lipids, lipoproteins and sterols will be analyzed at the randomization, before the operation and one month after the operation. The carotid arteries will be examined for their composition of sterols.
This study gives new information concerning the relationship between dietary consumption of plant sterols and stanols and the sterol composition of the carotid plaques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Plant StanolA group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation |
| 2 | Active comparator | Dietary Supplement: Plant SterolA group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic tight carotid plaques
- Age 40-80
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Plant StanolPlant stanols in margarines daily 2 grams | Dietary supplement | 1 |
| Plant SterolPlant sterols in margarines daily 2 grams | Dietary supplement | 2 |
Primary outcome
Sterols in serum and carotid plaques at the operation
Time frame: at operation and one month after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
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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 Plant Stanol and Plant Sterol in people with 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 2 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: finished, as of the sponsor's last update on 10 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sterols in serum and carotid plaques at the operation (time frame: at operation and one month after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2011.