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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Effect of Oxidized Plant Sterol Intake on Serum Concentrations of Plant Sterol Oxidation Products (POP)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: cookies enriched with POP


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>0 mg/d added POP | Other: cookies enriched with POP<br>* Cookies<br>|
| Active Comparator: low dosage<br>low added POP | Other: cookies enriched with POP<br>* Cookies<br>|
| Active Comparator: Medium dose<br>medium added POP | Other: cookies enriched with POP<br>* Cookies<br>|
| Active Comparator: Hige dose<br>high added POP | Other: cookies enriched with POP<br>* Cookies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POP (plant sterol oxidation products) value | To estimate the change from baseline in serum POP concentration after intake of various POP doses. | 0 to 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COP (cholesterol oxidation products) value | To estimate the change from baseline in serum COP concentrations after intake of various POP doses. | 0 to 42 days | 
| Ratio of serum POP concentration | To estimate the ratio of serum POP concentrations vs. COP concentrations after intake of various POP doses. | 0 to 42 days |