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

NCT03312816 | Completed

• 1 other identifier: FDS-SCC-2838
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• COP (cholesterol oxidation products) value

  0 to 42 days

• Ratio of serum POP concentration

  0 to 42 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

0 mg/d added POP

Other: cookies enriched with POP

low dosage

ACTIVE COMPARATOR

low added POP

Other: cookies enriched with POP

Medium dose

ACTIVE COMPARATOR

medium added POP

Other: cookies enriched with POP

Hige dose

ACTIVE COMPARATOR

high added POP

Other: cookies enriched with POP

Interventions

cookies enriched with POP OTHER

Cookies

Hige dose; Medium dose; Placebo; low dosage

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

Study Officials

• Christian Keicher, Dr

  Charité Research Organisation GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 18, 2017
• Study Start: October 16, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

DE (1)