High Blood Cholesterol LevelPhase 4NCT00485095
The Effect of Plant Sterol Supplement on Blood Cholesterol
A Phase 4 study testing Intake of plant sterols in people with High Blood Cholesterol Level, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Cholesterol Level
- What is being tested?
- Intake of plant sterols
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2007to Jul 2007
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 18-80 years old
- Total cholesterol: 4.5-7.5 mmol/l
- Triglycerides at or below 4.0 mmol/l
Who cannot join
- BMI at or above 35 kg/m2
- Secondary hyperlipidemia, included diabetes
- Hypertension (at og higher than 170/110)
- Coronar, perifery or cerebral vascular disease last 3 months
- Familial hypercholesterolemia
- Change in dose of statins, oestrogen or contraceptives last 3 months
Show all 12Show fewer
- Taking drugs which are known to interfere with the plasma level of cholesterol
- Chronic rheumatoid diseases or other diseases known to affect c-reactive protein
- Pregnancy
- Lactation
- Planning to reduce weight
- Taking plant sterols
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Lipidklinikken, Rikshospitalet Radiumhospitalet HF
Oslo
Rikshospitalet Radiumhospitalet HF, Oslo, Norway
Oslo
About this study
Official title: A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol
The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.
- Conditions
- High Blood Cholesterol Level
- Being tested
- Intake of plant sterols
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intake of plant sterolsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Blood Cholesterol LevelStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mills DA
- Investigators
- Leiv Ose, MD, Principal investigator, Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485095
- Sponsor's protocol ID
- 2.2006.3407
- Status last verified
- Feb 2009
- First submitted
- 11 Jun 2007
- Last updated
- 1 Jul 2011
- Results posted
- No
Publications
Ottestad I, Ose L, Wennersberg MH, Granlund L, Kirkhus B, Retterstol K. Phytosterol capsules and serum cholesterol in hypercholesterolemia: a randomized controlled trial. Atherosclerosis. 2013 Jun;228(2):421-5. doi: 10.1016/j.atherosclerosis.2013.03.001. Epub 2013 Mar 20.
PubMed 23623012
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol
- ClinicalTrials.gov ID
- NCT00485095
- Acronym / sponsor ID
- 2.2006.3407
- Conditions
- High Blood Cholesterol Level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Mills DA
- Study start
- Jan 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Jun 2007 (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.
The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 18-80 years old
- Total cholesterol: 4.5-7.5 mmol/l
- Triglycerides at or below 4.0 mmol/l
Key exclusion criteria (12 listed)
- BMI at or above 35 kg/m2
- Secondary hyperlipidemia, included diabetes
- Hypertension (at og higher than 170/110)
- Coronar, perifery or cerebral vascular disease last 3 months
- Familial hypercholesterolemia
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 |
|---|---|---|
| Intake of plant sterols | Behavioural | – |
Primary outcome
Not reported in the source record.
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 1 Jul 2011.
- Derived from this study: PubMed 23623012Ottestad I, Ose L, Wennersberg MH, Granlund L, Kirkhus B, Retterstol K. Phytosterol capsules and serum cholesterol in hypercholesterolemia: a randomized controlled trial. Atherosclerosis. 2013 Jun;228(2):421-5. doi: 10.1016/j.atherosclerosis.2013.03.001. Epub 2013 Mar 20.
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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.
Leiv Ose, MD principal investigator
Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intake of plant sterols in people with High Blood Cholesterol Level, run by Oslo University Hospital at 2 sites in Norway.
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 3 inclusion and 12 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 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00485095, which also lists 1 linked publication.
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 1 Jul 2011.