Vascular DiseasesNCT01803178
The Effect of Plant Sterols on Vascular Function
A study testing Plant Sterols in people with Vascular Diseases and Hypercholesterolemia, run by Unilever R&D at 1 site in Germany.
Trial summary
The main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (FMD). This study also aims to study the effect of plant sterols on pulse wave velocity (PWV), aortic augmentation index (Aix), central blood pressure (CBP), office blood… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases, Hypercholesterolemia
- What is being tested?
- Plant Sterols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Aug 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and post-menopausal women
- BMI ≥ 18 and ≤ 30 kg/m2.
- Aged between 40 - 65 years.
- Having elevated LDL-cholesterol concentrations at screening (130-190 mg/dL or 3.4-4.9 mmol/L).
- Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the research physician
Who cannot join
- Having (previous) cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions or diabetes mellitus.
- Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, ARB and ACE inhibitors), to be judged by the Principal Investigator.
- Use of medical treatment for elevated TG concentrations.
- Use of antibiotics in the three months prior to screening.
- Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (FMD).
This study also aims to study the effect of plant sterols on pulse wave velocity (PWV), aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP), blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will be assessed.
Read more
For all study outcomes, effect sizes and 95% confidence intervals will be estimated.
Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly increase FMD.
Read the detailed description
Plant sterols are well known for their LDL-cholesterol lowering benefit. Elevated cholesterol and especially LDL-cholesterol concentrations are established risk factors for coronary heart disease (CHD) and reducing these concentrations by dietary modification or drug treatment have been shown to reduce the risk of CHD. Direct evidence supporting a reduced risk of CHD has so far not been generated. Investigating the effects of consuming plant sterols on intermediate risk factors beyond cholesterol-lowering is therefore warranted.
- Conditions
- Vascular Diseases, Hypercholesterolemia
- Being tested
- Plant Sterols, Placebo Product
- Keywords
- vascular function, plant sterols, blood lipids
- Medical subject headings
- Vascular Diseases, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant SterolsDietary supplement
Placebo ProductDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Plant Sterols | Active comparator | Plant Sterols Receives: Dietary Supplement: Plant Sterols |
| Placebo Product | Placebo comparator | Placebo Product Receives: Dietary Supplement: Placebo Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in flow-mediated dilation
Measured: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Secondary outcomes (1)
Change in pulse wave velocity
Measured: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wieneke Koppenol, MSc, Study director, Unilever Research & Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803178
- Sponsor's protocol ID
- FDS-SCC-0574
- Status last verified
- Feb 2013
- First submitted
- 26 Feb 2013
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ras RT, Fuchs D, Koppenol WP, Schalkwijk CG, Otten-Hofman A, Garczarek U, Greyling A, Wagner F, Trautwein EA. Effect of a plant sterol-enriched spread on biomarkers of endothelial dysfunction and low-grade inflammation in hypercholesterolaemic subjects. J Nutr Sci. 2016 Dec 6;5:e44. doi: 10.1017/jns.2016.40. eCollection 2016.
PubMed 28620471Ras RT, Koppenol WP, Garczarek U, Otten-Hofman A, Fuchs D, Wagner F, Trautwein EA. Increases in plasma plant sterols stabilize within four weeks of plant sterol intake and are independent of cholesterol metabolism. Nutr Metab Cardiovasc Dis. 2016 Apr;26(4):302-9. doi: 10.1016/j.numecd.2015.11.007. Epub 2015 Dec 12.
PubMed 26806045Ras RT, Fuchs D, Koppenol WP, Garczarek U, Greyling A, Keicher C, Verhoeven C, Bouzamondo H, Wagner F, Trautwein EA. The effect of a low-fat spread with added plant sterols on vascular function markers: results of the Investigating Vascular Function Effects of Plant Sterols (INVEST) study. Am J Clin Nutr. 2015 Apr;101(4):733-41. doi: 10.3945/ajcn.114.102053.
PubMed 25809853
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Plant Sterols on Vascular Function
- ClinicalTrials.gov ID
- NCT01803178
- Acronym / sponsor ID
- FDS-SCC-0574
- Conditions
- Vascular Diseases, Hypercholesterolemia
- Keywords
- vascular function, plant sterols, blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Mar 2013 (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 main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (FMD).
This study also aims to study the effect of plant sterols on pulse wave velocity (PWV), aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP), blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will be assessed.
For all study outcomes, effect sizes and 95% confidence intervals will be estimated.
Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly increase FMD.
Detailed description
Plant sterols are well known for their LDL-cholesterol lowering benefit. Elevated cholesterol and especially LDL-cholesterol concentrations are established risk factors for coronary heart disease (CHD) and reducing these concentrations by dietary modification or drug treatment have been shown to reduce the risk of CHD. Direct evidence supporting a reduced risk of CHD has so far not been generated. Investigating the effects of consuming plant sterols on intermediate risk factors beyond cholesterol-lowering is therefore warranted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant Sterols | Active comparator | Dietary Supplement: Plant SterolsPlant Sterols |
| Placebo Product | Placebo comparator | Dietary Supplement: Placebo ProductPlacebo Product |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Apparently healthy men and post-menopausal women
- BMI ≥ 18 and ≤ 30 kg/m2.
- Aged between 40 - 65 years.
- Having elevated LDL-cholesterol concentrations at screening (130-190 mg/dL or 3.4-4.9 mmol/L).
- Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the research physician
Key exclusion criteria (5 listed)
- Having (previous) cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions or diabetes mellitus.
- Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, ARB and ACE inhibitors), to be judged by the Principal Investigator.
- Use of medical treatment for elevated TG concentrations.
- Use of antibiotics in the three months prior to screening.
- Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
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 | Dietary supplement | Plant Sterols |
| Placebo Product | Dietary supplement | Placebo Product |
Primary outcome
Change in flow-mediated dilation
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
1 secondary outcome
Change in pulse wave velocity
Time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention
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 28 Oct 2013.
- Derived from this study: PubMed 28620471Ras RT, Fuchs D, Koppenol WP, Schalkwijk CG, Otten-Hofman A, Garczarek U, Greyling A, Wagner F, Trautwein EA. Effect of a plant sterol-enriched spread on biomarkers of endothelial dysfunction and low-grade inflammation in hypercholesterolaemic subjects. J Nutr Sci. 2016 Dec 6;5:e44. doi: 10.1017/jns.2016.40. eCollection 2016.
- Derived from this study: PubMed 26806045Ras RT, Koppenol WP, Garczarek U, Otten-Hofman A, Fuchs D, Wagner F, Trautwein EA. Increases in plasma plant sterols stabilize within four weeks of plant sterol intake and are independent of cholesterol metabolism. Nutr Metab Cardiovasc Dis. 2016 Apr;26(4):302-9. doi: 10.1016/j.numecd.2015.11.007. Epub 2015 Dec 12.
- Derived from this study: PubMed 25809853Ras RT, Fuchs D, Koppenol WP, Garczarek U, Greyling A, Keicher C, Verhoeven C, Bouzamondo H, Wagner F, Trautwein EA. The effect of a low-fat spread with added plant sterols on vascular function markers: results of the Investigating Vascular Function Effects of Plant Sterols (INVEST) study. Am J Clin Nutr. 2015 Apr;101(4):733-41. doi: 10.3945/ajcn.114.102053.
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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.
Wieneke Koppenol, MSc study director
Unilever Research & Development
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 Sterols in people with Vascular Diseases and Hypercholesterolemia, run by Unilever R&D at 1 site in Germany.
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 5 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 28 Oct 2013. 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 Germany. 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?
Change in flow-mediated dilation (time frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention). 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 NCT01803178, which also lists 3 linked publications.
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 28 Oct 2013.