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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: cookies enriched with POP

• Registration Number: NCT03312816
• Lead Sponsor: Unilever R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-12
• Study Start: 2017-10-16
• Study First Posted: 2017-10-18
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-08
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dosage	cookies enriched with POP	low added POP
Medium dose	cookies enriched with POP	medium added POP
Placebo	cookies enriched with POP	0 mg/d added POP
Hige dose	cookies enriched with POP	high added POP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany