The Effect of Plant Sterols on Vascular Function

NCT01803178 | Completed

• 1 other identifier: FDS-SCC-0574
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases; Hypercholesterolemia

Keywords

vascular function; plant sterols; blood lipids

Outcome Measures

Primary Outcomes (1)

• Change in flow-mediated dilation

  At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Secondary Outcomes (1)

• Change in pulse wave velocity

  At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Other Outcomes (6)

• Change in blood lipids

  At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention

• Change in plasma plant sterols

  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

  At baseline (after 4 weeks run-in period) and after 12 weeks intervention

Study Arms (2)

Plant Sterols

ACTIVE COMPARATOR

Plant Sterols

Dietary Supplement: Plant Sterols

Placebo Product

PLACEBO COMPARATOR

Placebo Product

Dietary Supplement: Placebo Product

Interventions

Plant Sterols DIETARY_SUPPLEMENT

Plant Sterols

Placebo Product DIETARY_SUPPLEMENT

Placebo Product

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

Charité Research Organisation

Berlin, Germany

Location

Related Publications (3)

• 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.

  PMID: 28620471 DERIVED

• 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.

  PMID: 26806045 DERIVED

• 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.

  PMID: 25809853 DERIVED

MeSH Terms

Conditions

Vascular Diseases; Hypercholesterolemia

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Officials

• Wieneke Koppenol, MSc

  Unilever Research & Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 28, 2013

Record last verified: 2013-02

Locations

DE (1)