HypercholesterolemiaNCT02221297
Lipid-lowering Effect of a Plant Stanol Ester Supplement Product
A study testing Supplement product with plant stanol ester in people with Hypercholesterolemia and Hyperlipidemias, run by Raisio Group.
Trial summary
Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- What is being tested?
- Supplement product with plant stanol ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Nov 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and female over 18 years old
- serum LDL cholesterol > 3.0 mmol/L
- BMI < 35
- subjects must voluntarily sign the informed consent
Who cannot join
- subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
- subjects with any hepatic or renal disorder according to medical history
- subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
- subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
- subjects who have history of temporal ischemic attack or stroke within six months prior to screening
- subjects who have a history of cancer or other malignant disease within the past five years
Show all 10Show fewer
- subjects who are consuming more than 15 portions of alcohol / week
- subjects who are pregnant or lactating
- subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
- subjects with intolerance to any ingredient of the test product
About this study
Official title: Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product
Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.
- Conditions
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- Being tested
- Supplement product with plant stanol ester
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement product with plant stanol esterDietary supplement
2 grams plant stanols consumed with a meal daily for 3 to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Supplement product with plant stanol ester | Experimental | Not described Receives: Dietary Supplement: Supplement product with plant stanol ester |
| Placebo supplement product | Placebo comparator | Not described Receives: Dietary Supplement: Supplement product with plant stanol ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportional change in serum LDL cholesterol
Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
Measured: 3 to 4 weeks
Secondary outcomes (5)
Proportional change in total cholesterol
Proportional change [end of intervention - start of intervention] in serum total cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
Measured: 3 to 4 weeks
Proportional change in non-HDL-cholesterol
Proportional change [end of intervention - start of intervention] in serum non-HDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
Measured: 3 to 4 weeks
Proportional change in serum triglycerides
Proportional change [end of intervention - start of intervention] in serum triglycerides between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
Measured: 3 to 4 weeks
Proportional change in lipids in all study participants
Proportional change [end of intervention - start of intervention] in serum lipids in all study participants (ITT analysis)
Measured: 3 to 4 weeks
Proportional change in lipids in subjects without metabolic derangements
Proportional change [end of intervention - start of intervention] in serum lipids in study participants without metabolic derangements (excluding those with type two diabetes and/or metabolic syndrome)
Measured: 3 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 posted20 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raisio Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Institute HUCH Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221297
- Sponsor's protocol ID
- CL2014_035
- Status last verified
- Oct 2015
- First submitted
- 19 Aug 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product
- ClinicalTrials.gov ID
- NCT02221297
- Acronym / sponsor ID
- CL2014_035
- Conditions
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Raisio GroupIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Institute HUCH Ltd
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Aug 2014 (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.
Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplement product with plant stanol ester | Experimental | Dietary Supplement: Supplement product with plant stanol ester |
| Placebo supplement product | Placebo comparator | Dietary Supplement: Supplement product with plant stanol ester |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and female over 18 years old
- serum LDL cholesterol > 3.0 mmol/L
- BMI < 35
- subjects must voluntarily sign the informed consent
Key exclusion criteria (10 listed)
- subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
- subjects with any hepatic or renal disorder according to medical history
- subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
- subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
- subjects who have history of temporal ischemic attack or stroke within six months prior to screening
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 |
|---|---|---|
| Supplement product with plant stanol ester2 grams plant stanols consumed with a meal daily for 3 to 4 weeks | Dietary supplement | Placebo supplement product, Supplement product with plant stanol ester |
Primary outcome
Proportional change in serum LDL cholesterol
Time frame: 3 to 4 weeks
Proportional change [end of intervention - start of intervention] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
5 secondary outcomes
Proportional change in total cholesterol
Time frame: 3 to 4 weeks
Proportional change in non-HDL-cholesterol
Time frame: 3 to 4 weeks
Proportional change in serum triglycerides
Time frame: 3 to 4 weeks
Proportional change in lipids in all study participants
Time frame: 3 to 4 weeks
Proportional change in lipids in subjects without metabolic derangements
Time frame: 3 to 4 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 29 Oct 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement product with plant stanol ester in people with Hypercholesterolemia and Hyperlipidemias, run by Raisio Group.
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 4 inclusion and 10 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportional change in serum LDL cholesterol (time frame: 3 to 4 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 29 Oct 2015.