Status:
COMPLETED
Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Lead Sponsor:
Unilever R&D
Conditions:
Healthy
Eligibility:
All Genders
40-75 years
Phase:
NA
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 am...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03312816
Start Date
October 16 2017
End Date
December 8 2017
Last Update
June 7 2018
Active Locations (1)
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1
Charité Research Organisation GmbH
Berlin, Germany, 10117