Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Status
Completed
Conditions
Healthy
Treatments
Other: cookies enriched with POP
Details and patient eligibility
About
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.
Enrollment
60 patients
Sex
All
Ages
40 to 75 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
60 participants in 4 patient groups, including a placebo group
Placebo
Placebo Comparator group
Description:
0 mg/d added POP
Treatment:
Other: cookies enriched with POP
low dosage
Active Comparator group
Description:
low added POP
Treatment:
Other: cookies enriched with POP
Medium dose
Active Comparator group
Description:
medium added POP
Treatment:
Other: cookies enriched with POP
Hige dose
Active Comparator group
Description:
high added POP
Treatment:
Other: cookies enriched with POP
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems