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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: cookies enriched with POP

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0 mg/d added POP	Other: cookies enriched with POP; Cookies
Active Comparator: low dosage; low added POP	Other: cookies enriched with POP; Cookies
Active Comparator: Medium dose; medium added POP	Other: cookies enriched with POP; Cookies
Active Comparator: Hige dose; high added POP	Other: cookies enriched with POP; Cookies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Unilever R&D
• Investigators: Principal Investigator: Christian Keicher, Dr, Charité Research Organisation GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FDS-SCC-2838

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No