Healthy
Conditions
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.
Interventions
OTHERcookies enriched with POP
Cookies
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POP (plant sterol oxidation products) value | 0 to 42 days | To estimate the change from baseline in serum POP concentration after intake of various POP doses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COP (cholesterol oxidation products) value | 0 to 42 days | To estimate the change from baseline in serum COP concentrations after intake of various POP doses. |
| Ratio of serum POP concentration | 0 to 42 days | To estimate the ratio of serum POP concentrations vs. COP concentrations after intake of various POP doses. |
Countries
Germany
Outcome results
None listed