Back to resultsThe Effect of Plant Sterols on Vascular Function
Primary Purpose
Vascular Diseases, Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Plant Sterols
Placebo Product
Sponsored by
About this trial
This is an interventional supportive care trial for Vascular Diseases focused on measuring vascular function, plant sterols, blood lipids
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Charité Research Organisation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Plant Sterols
Placebo Product
Arm Description
Plant Sterols
Placebo Product
Outcomes
Primary Outcome Measures
Change in flow-mediated dilation
Secondary Outcome Measures
Change in pulse wave velocity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01803178
Brief Title
The Effect of Plant Sterols on Vascular Function
Official Title
The Effect of Plant Sterols on Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Hypercholesterolemia
Keywords
vascular function, plant sterols, blood lipids
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plant Sterols
Arm Type
Active Comparator
Arm Description
Plant Sterols
Arm Title
Placebo Product
Arm Type
Placebo Comparator
Arm Description
Placebo Product
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant Sterols
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Product
Primary Outcome Measure Information:
Title
Change in flow-mediated dilation
Time Frame
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Secondary Outcome Measure Information:
Title
Change in pulse wave velocity
Time Frame
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Other Pre-specified Outcome Measures:
Title
Change in blood lipids
Time Frame
At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
Title
Change in plasma plant sterols
Time Frame
At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention
Title
Change in plasma biomarkers of endothelial dysfunction and low-grade inflammation
Time Frame
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Title
Change in aortic augmentation index
Time Frame
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Title
Change in central blood pressure
Time Frame
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
Title
Change in office blood pressure
Time Frame
At baseline (after 4 weeks run-in period) and after 12 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wieneke Koppenol, MSc
Organizational Affiliation
Unilever Research & Development
Official's Role
Study Director
Facility Information:
Facility Name
Charité Research Organisation
City
Berlin
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28620471
Citation
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.
Results Reference
derived
PubMed Identifier
26806045
Citation
Ras 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.
Results Reference
derived
PubMed Identifier
25809853
Citation
Ras 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.
Results Reference
derived
Learn more about this trial
The Effect of Plant Sterols on Vascular Function
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