The Effect of Plant Sterols on Vascular Function

• ClinicalTrials.gov Identifier: NCT01803178
• Recruitment Status: Completed
• First Posted: March 4, 2013
• Last Update Posted: October 28, 2013
• Sponsor: Unilever R&D
• Information provided by (Responsible Party): Unilever R&D

Tracking Information

• First Submitted Date: February 26, 2013
• First Posted Date: March 4, 2013
• Last Update Posted Date: October 28, 2013
• Study Start Date: February 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 5, 2013): Change in flow-mediated dilation [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
• Original Primary Outcome Measures (submitted: February 28, 2013): Change in FMD [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
• Current Secondary Outcome Measures (submitted: March 5, 2013): Change in pulse wave velocity [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
• Original Secondary Outcome Measures (submitted: February 28, 2013): Change in PWV [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]

Current Other Pre-specified Outcome Measures (submitted: March 5, 2013)

• Change in blood lipids [ Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention ]
• Change in plasma plant sterols [ Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention ]
• 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 ]
• Change in aortic augmentation index [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
• Change in central blood pressure [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
• Change in office blood pressure [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]

Original Other Pre-specified Outcome Measures (submitted: February 28, 2013)

• Change in blood lipids [ Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention ]
• Change in plasma plant sterols [ Time Frame: At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention ]
• 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 ]
• Change in Aix [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
• Change in CBP [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]
• Change in office BP [ Time Frame: At baseline (after 4 weeks run-in period) and after 12 weeks intervention ]

Descriptive Information

• Brief Title: The Effect of Plant Sterols on Vascular Function
• Official Title: The Effect of Plant Sterols on Vascular Function

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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• Vascular Diseases
• Hypercholesterolemia

Intervention

• Dietary Supplement: Plant Sterols
• Dietary Supplement: Placebo Product

Study Arms

• Active Comparator: Plant Sterols
  Plant Sterols
  Intervention: Dietary Supplement: Plant Sterols
• Placebo Comparator: Placebo Product
  Placebo Product
  Intervention: Dietary Supplement: Placebo Product

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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2013): 240
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01803178
• Other Study ID Numbers: FDS-SCC-0574
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Unilever R&D
• Study Sponsor: Unilever R&D
• Collaborators: Not Provided

Investigators

• Study Director: Wieneke Koppenol, MSc; Unilever Research & Development

• PRS Account: Unilever R&D
• Verification Date: February 2013