The Effect of Plant Sterols on Vascular Function

• Sponsor: Unilever R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01803178
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 40.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases; Hypercholesterolemia	Dietary Supplement: Plant Sterols; Dietary Supplement: Placebo Product	N/A

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

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Plant Sterols on Vascular Function
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Plant Sterols Plant Sterols	Dietary Supplement: Plant Sterols
Placebo Comparator: Placebo Product Placebo Product	Dietary Supplement: Placebo Product

Outcome Measures

Primary Outcome Measures

1. Change in flow-mediated dilation [At baseline (after 4 weeks run-in period) and after 12 weeks intervention]

Secondary Outcome Measures

1. Change in pulse wave velocity [At baseline (after 4 weeks run-in period) and after 12 weeks intervention]

Other Outcome Measures

1. Change in blood lipids [At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention]

2. Change in plasma plant sterols [At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention]

3. Change in plasma biomarkers of endothelial dysfunction and low-grade inflammation [At baseline (after 4 weeks run-in period) and after 12 weeks intervention]

4. Change in aortic augmentation index [At baseline (after 4 weeks run-in period) and after 12 weeks intervention]

5. Change in central blood pressure [At baseline (after 4 weeks run-in period) and after 12 weeks intervention]

6. Change in office blood pressure [At baseline (after 4 weeks run-in period) and after 12 weeks intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Research Organisation	Berlin		Germany

Sponsors and Collaborators

• Unilever R&D

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unilever R&D
• ClinicalTrials.gov Identifier: NCT01803178
• Other Study ID Numbers: FDS-SCC-0574
• First Posted: Mar 4, 2013
• Last Update Posted: Oct 28, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Unilever R&D: vascular function; plant sterols; blood lipids
• Additional relevant MeSH terms: Vascular Diseases; Hypercholesterolemia

Study Results

No Results Posted as of Oct 28, 2013