Completed

The Effect of Plant Sterols on Vascular Function

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Plant Sterols

+ Placebo Product

Dietary Supplement
Who is being recruted

Cardiovascular Diseases+5

+ Hyperlipidemias

+ Metabolic Diseases

From 40 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUnilever R&D
Last updated: October 28, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01803178
Principal SponsorUnilever R&D
Last updated: October 28, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersHypercholesterolemiaVascular Diseases

Criteria

5 inclusion criteria required to participate
Aged between 40 - 65 years
Apparently healthy men and post-menopausal women
BMI >= 18 and <= 30 kg/m2
Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the research physician
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5 exclusion criteria prevent from participating
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
Having (previous) cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure), systemic inflammatory conditions or diabetes mellitus
Use of antibiotics in the three months prior to screening
Use of medical treatment for elevated TG concentrations
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Plant Sterols

Group II

Placebo
Placebo Product

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Charité Research Organisation

Berlin, GermanyOpen Charité Research Organisation in Google Maps
CompletedOne Study Center