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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312816
• Other study ID #: FDS-SCC-2838
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: June 2018
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• cookies enriched with POP
Cookies

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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