Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2017-12-08

Brief Summary

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The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with four study arms. Sixty subjects will be randomly allocated to consume study products containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6 weeks.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

0 mg/d added POP

Group Type PLACEBO_COMPARATOR

cookies enriched with POP

Intervention Type OTHER

Cookies

low dosage

low added POP

Group Type ACTIVE_COMPARATOR

cookies enriched with POP

Intervention Type OTHER

Cookies

Medium dose

medium added POP

Group Type ACTIVE_COMPARATOR

cookies enriched with POP

Intervention Type OTHER

Cookies

Hige dose

high added POP

Group Type ACTIVE_COMPARATOR

cookies enriched with POP

Intervention Type OTHER

Cookies

Interventions

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cookies enriched with POP

Cookies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy men and women as judged by study physician.
* BMI \> 18 and \< 35 kg/m2.
* Total cholesterol levels at screening ≥5.0 and ≤8.0 mmol/L
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the study physician.

Exclusion Criteria

* Recently (\<6 months) diagnosed with cardiovascular event(s) (stroke, TIA (Transient ischemic attack), angina, myocardial infarction, heart failure), revascularization or systemic inflammatory conditions.
* Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study.
* Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, angiotensin receptor blockers (ARB) and ACE (Angiotensin-converting enzyme) inhibitors)), to be judged by the principal investigator.
* Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to Day -2.
* Pregnant or lactating women.
* Reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male).
* Reported intense sporting activities \> 10 hours/week.
* Reported weight loss or gain of 3 kg or more during a period of 6 months prior to screening.
* Currently on a medically- or self-prescribed diet, or slimming diet, or the intention to use any kind of diet during the study.
* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes