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

Sponsor
Unilever R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT03312816
Collaborator
(none)
60
Enrollment
1
Location
4
Arms
1.7
Actual Duration (Months)
34.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: cookies enriched with POP
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
The Effect of Oxidized Plant Sterol Intake on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Actual Study Start Date :
Oct 16, 2017
Actual Primary Completion Date :
Dec 8, 2017
Actual Study Completion Date :
Dec 8, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité Research Organisation GmbH Berlin Germany 10117

Sponsors and Collaborators

  • Unilever R&D

Investigators

  • Principal Investigator: Christian Keicher, Dr, Charité Research Organisation GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Unilever R&D
ClinicalTrials.gov Identifier:
NCT03312816
Other Study ID Numbers:
  • FDS-SCC-2838
First Posted:
Oct 18, 2017
Last Update Posted:
Jun 7, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 7, 2018