DyslipidemiaPhase 4NCT00441480
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
A Phase 4 study testing Plant sterols esters in people with Dyslipidemia, run by Enzymotec at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Plant sterols esters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, >18 years old and ≤ 70 years old, capable and willing to give written informed consent.
- Subject must have hyperlipidemia at the screening visit and at the end of the run-in period, defined as: fasting plasma triglycerides > 150 mg/dl and < 500 mg/dl, LDL-cholesterol > 130 mg/dl and < 190 mg/dl.
- Fasting plasma glucose (FPG) levels at the screening visit < 110 mg/dl.
- Female patient who is of reproductive potential agree to use acceptable methods of birth control
- Female patient who is currently receiving hormone replacement therapy continuously 12 weeks before visit 1 (on stable dose) and will agree to do so during the study.
Who cannot join
- Receiving medications or supplements known to affect lipid metabolism.
- Uncontrolled hypertension or thyroid disease.
- Consume unusual diets - will be determined at the discretion of the investigator.
- Gained or lost more than 3 kg during the run-in period.
- Patient has history of malignancy ≤ 5 years.
- Patients with clinical ischemic CV disease on treatment
Show all 13Show fewer
- Consume 200 grams fish x 2 a week.
- Gastrointestinal disease or any disease that the investigator feels would compromise the patient safety or limit his/her successful participation to the study.
- Patient has type 1 or type 2 diabetes mellitus.
- Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- Patient has had active peptic ulcer disease within 3 months of visit 1.
- Woman patient is pregnant or breast-feeding or expecting to conceive during the study.
- Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or soy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects
The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects.
Read the detailed description
Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and biliary cholesterol re-absorption, thereby reducing blood cholesterol levels, while consumption of n-3 is associated with a significant reduction in plasma triglyceride concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors of CHD, like anti-inflammatory and anti-thrombotic.
The primary objective of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects. In addition the supplement efficacy to lower other CVD-related risk factors of healthy will be evaluated.
- Conditions
- Dyslipidemia
- Being tested
- Plant sterols esters, placebo
- Keywords
- Hypercholesterolemia, Hypertriglyceridemia, Plant sterol, Cholesterol, Fish oil
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterols estersDietary supplement
Also called PS-FO
1.6g phytosterols and 1.3g omega-3 fatty acids per day
placeboDietary supplement
4 gr of corn oil
| Study group | Role | What they receive |
|---|---|---|
| Plant sterol esters | Active comparator | plant sterols esterified to fish oil fatty acids Receives: Dietary Supplement: Plant sterols esters |
| placebo | Placebo comparator | Corn oil Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Cholesterol
Average of blood test results at -10 and 0 days (before and after run-in period)
Measured: at baseline
LDL-C
Blood test results following 12 weeks of intervention
Measured: 12 weeks
Secondary outcomes (12)
Triglycerides
Average of blood test results at -10 and 0 weeks (before and after run-in period)
Measured: at baseline
Triglycerides
Blood test results following 12 weeks of intervention
Measured: 12 weeks
Total Cholesterol
Average of blood test results at -10 and 0 weeks (before and after run-in period)
Measured: at baseline
Total Cholesterol
Blood test results following 12 weeks of intervention
Measured: 12 weeks
HDL Cholesterol
Average of blood test results at -10 and 0 weeks (before and after run-in period)
Measured: at baseline
HDL-cholestrol
Blood test results following 12 weeks of intervention
Measured: 12 weeks
CRP
Blood test results on day 0 of High sensitivity C Reactive Protein
Measured: at baseline
CRP
Blood test results following 12 weeks of intervention of High sensetivity C reactive protein
Measured: 12 weeks
Apolipoprotein B100
Blood test results on day 0
Measured: at baseline
Apolipoprotein B100
Blood test results follwing 12 weeks of intervention
Measured: 12 weeks
Apolipoprotein A
Blood test on day 0
Measured: at baseline
Apolipoprotein A
Blood test results following 12 weeks of intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dror Harats, M.D., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441480
- Sponsor's protocol ID
- CardiaBeat_003
- Status last verified
- Jan 2012
- First submitted
- 28 Feb 2007
- Last updated
- 13 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bitzur R, Cohen H, Cohen T, Dror TW, Herzog Y, Lifshitz Y, Lubish T, Harats D, Rubinstein A. The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):429-37. doi: 10.1007/s10557-010-6249-5.
PubMed 20617456
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects
- ClinicalTrials.gov ID
- NCT00441480
- Acronym / sponsor ID
- CardiaBeat_003
- Conditions
- Dyslipidemia
- Keywords
- Hypercholesterolemia, Hypertriglyceridemia, Plant sterol, Cholesterol, Fish oil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Posted 14 Aug 2009
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 plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects.
Detailed description
Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and biliary cholesterol re-absorption, thereby reducing blood cholesterol levels, while consumption of n-3 is associated with a significant reduction in plasma triglyceride concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors of CHD, like anti-inflammatory and anti-thrombotic.
The primary objective of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects. In addition the supplement efficacy to lower other CVD-related risk factors of healthy will be evaluated.
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 |
|---|---|---|
| Plant sterol esters | Active comparator | Dietary Supplement: Plant sterols estersplant sterols esterified to fish oil fatty acids |
| placebo | Placebo comparator | Dietary Supplement: placeboCorn oil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, >18 years old and ≤ 70 years old, capable and willing to give written informed consent.
- Subject must have hyperlipidemia at the screening visit and at the end of the run-in period, defined as: fasting plasma triglycerides > 150 mg/dl and < 500 mg/dl, LDL-cholesterol > 130 mg/dl and < 190 mg/dl.
- Fasting plasma glucose (FPG) levels at the screening visit < 110 mg/dl.
- Female patient who is of reproductive potential agree to use acceptable methods of birth control
- Female patient who is currently receiving hormone replacement therapy continuously 12 weeks before visit 1 (on stable dose) and will agree to do so during the study.
Key exclusion criteria (13 listed)
- Receiving medications or supplements known to affect lipid metabolism.
- Uncontrolled hypertension or thyroid disease.
- Consume unusual diets - will be determined at the discretion of the investigator.
- Gained or lost more than 3 kg during the run-in period.
- Patient has history of malignancy ≤ 5 years.
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 sterols estersAlso: PS-FO1.6g phytosterols and 1.3g omega-3 fatty acids per day | Dietary supplement | Plant sterol esters |
| placebo4 gr of corn oil | Dietary supplement | placebo |
Primary outcome
LDL Cholesterol
Time frame: at baseline
Average of blood test results at -10 and 0 days (before and after run-in period)
LDL-C
Time frame: 12 weeks
Blood test results following 12 weeks of intervention
12 secondary outcomes
Triglycerides
Time frame: at baseline
Triglycerides
Time frame: 12 weeks
Total Cholesterol
Time frame: at baseline
Total Cholesterol
Time frame: 12 weeks
HDL Cholesterol
Time frame: at baseline
HDL-cholestrol
Time frame: 12 weeks
CRP
Time frame: at baseline
CRP
Time frame: 12 weeks
Apolipoprotein B100
Time frame: at baseline
Apolipoprotein B100
Time frame: 12 weeks
Apolipoprotein A
Time frame: at baseline
Apolipoprotein A
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20617456Bitzur R, Cohen H, Cohen T, Dror TW, Herzog Y, Lifshitz Y, Lubish T, Harats D, Rubinstein A. The metabolic effects of omega-3 plant sterol esters in mixed hyperlipidemic subjects. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):429-37. doi: 10.1007/s10557-010-6249-5.
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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.
Dror Harats, M.D. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plant sterols esters in people with Dyslipidemia, run by Enzymotec at 1 site in Israel.
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 5 inclusion and 13 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 13 Jan 2012. 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 Israel. 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.
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?
Yes. Results are posted in the registry (first posted 14 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
LDL Cholesterol (time frame: at baseline). The study lists 2 primary outcomes in all. 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 NCT00441480, 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 13 Jan 2012.