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CompletedNCT03312816Updated Jun 7, 2018

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

An interventional study of cookies enriched with POP in Healthy, sponsored by Unilever R&D. Completed at 1 site in Germany. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-07.

Sponsored by Unilever R&D · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    0 mg/d added POP

    Other: cookies enriched with POP

  • Active comparator
    low dosage

    low added POP

    Other: cookies enriched with POP

  • Active comparator
    Medium dose

    medium added POP

    Other: cookies enriched with POP

  • Active comparator
    Hige dose

    high added POP

    Other: cookies enriched with POP

Interventions

  • Othercookies enriched with POP

    Cookies

05

What researchers measure

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.

    Time frame: 0 to 42 days

Secondary outcomes

  1. COP (cholesterol oxidation products) value

    To estimate the change from baseline in serum COP concentrations after intake of various POP doses.

    Time frame: 0 to 42 days

  2. Ratio of serum POP concentration

    To estimate the ratio of serum POP concentrations vs. COP concentrations after intake of various POP doses.

    Time frame: 0 to 42 days

06

Study locations

1 site
  • Charité Research Organisation GmbH
    Berlin, 10117, Germany
07

Registry details

Key details

Study ID
NCT03312816
Lead sponsor
Unilever R&D
Responsible party
Sponsor
First posted
Oct 18, 2017
Start date
Oct 16, 2017
Primary completion
Dec 8, 2017
Completion
Dec 8, 2017
Last update
Jun 7, 2018

Study contacts

Christian Keicher, Dr
principal investigator · Charité Research Organisation GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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