Elevated Blood LipidsNCT00920894
Effect of Plant Stanol Esters on Blood Lipids
A study testing plant stanol ester in people with Elevated Blood Lipids, run by Clinical Life Sciences Ltd. at 1 site in Finland.
Trial summary
This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Elevated Blood Lipids
- What is being tested?
- plant stanol ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Nov 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated blood lipids
- Body Mass Index < 35 kg/m2
- Stable body weight
Who cannot join
- Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
- Severe obesity
- Hyperglycemia
- Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
- Hepatic, kidney or thyroid disease or disorder
- Pregnancy or breast feeding
- Severe intolerance or allergy to any ingredient of test product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration
This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations
Read the detailed description
The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.
This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.
- Conditions
- Elevated Blood Lipids
- Being tested
- plant stanol ester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant stanol esterDietary supplement
the effect of plant stanol esters on plasma lipids
| Study group | Role | What they receive |
|---|---|---|
| yoghurt type minidrink containing plant stanol ester | Experimental | Not described Receives: Dietary Supplement: plant stanol ester |
| yoghurt type minidrink without plant stanol ester | Placebo comparator | Not described Receives: Dietary Supplement: plant stanol ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma lipids
Measured: 10 weeks
Secondary outcomes (1)
plasma lipoprotein lipids non-cholesterol sterols
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood LipidsStudies 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Life Sciences Ltd.
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920894
- Sponsor's protocol ID
- Kainuu PlantStanol Ester Study
- Status last verified
- Nov 2009
- First submitted
- 12 Jun 2009
- Last updated
- 5 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration
- ClinicalTrials.gov ID
- NCT00920894
- Acronym / sponsor ID
- Kainuu PlantStanol Ester Study
- Conditions
- Elevated Blood Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Clinical Life Sciences Ltd.University, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 Jun 2009 (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 measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations
Detailed description
The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.
This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoghurt type minidrink containing plant stanol ester | Experimental | Dietary Supplement: plant stanol ester |
| yoghurt type minidrink without plant stanol ester | Placebo comparator | Dietary Supplement: plant stanol ester |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elevated blood lipids
- Body Mass Index < 35 kg/m2
- Stable body weight
Key exclusion criteria (7 listed)
- Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
- Severe obesity
- Hyperglycemia
- Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
- Hepatic, kidney or thyroid disease or disorder
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 stanol esterthe effect of plant stanol esters on plasma lipids | Dietary supplement | yoghurt type minidrink containing plant stanol ester, yoghurt type minidrink without plant stanol ester |
Primary outcome
plasma lipids
Time frame: 10 weeks
1 secondary outcome
plasma lipoprotein lipids non-cholesterol sterols
Time frame: 10 weeks
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 5 Nov 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ester in people with Elevated Blood Lipids, run by Clinical Life Sciences Ltd. 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 3 inclusion and 7 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 5 Nov 2009. 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?
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?
plasma lipids (time frame: 10 weeks). 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 5 Nov 2009.