HealthyNCT03312816
Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)
A study testing cookies enriched with POP in people with Healthy, run by Unilever R&D at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cookies enriched with POP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2017to 8 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- cookies enriched with POP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cookies enriched with POPOther
Cookies
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0 mg/d added POP Receives: Other: cookies enriched with POP |
| low dosage | Active comparator | low added POP Receives: Other: cookies enriched with POP |
| Medium dose | Active comparator | medium added POP Receives: Other: cookies enriched with POP |
| Hige dose | Active comparator | high added POP Receives: Other: cookies enriched with POP |
What is being measured
The primary outcome is the main question the study is designed to answer.
POP (plant sterol oxidation products) value
To estimate the change from baseline in serum POP concentration after intake of various POP doses.
Measured: 0 to 42 days
Secondary outcomes (2)
COP (cholesterol oxidation products) value
To estimate the change from baseline in serum COP concentrations after intake of various POP doses.
Measured: 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.
Measured: 0 to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start16 Oct 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Keicher, Dr, Principal investigator, Charité Research Organisation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312816
- Sponsor's protocol ID
- FDS-SCC-2838
- Status last verified
- Jun 2018
- First submitted
- 12 Oct 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxidized Plant Sterol Intake on Serum Concentrations of Plant Sterol Oxidation Products (POP)
- ClinicalTrials.gov ID
- NCT03312816
- Acronym / sponsor ID
- FDS-SCC-2838
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: cookies enriched with POP0 mg/d added POP |
| low dosage | Active comparator | Other: cookies enriched with POPlow added POP |
| Medium dose | Active comparator | Other: cookies enriched with POPmedium added POP |
| Hige dose | Active comparator | Other: cookies enriched with POPhigh added POP |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cookies enriched with POPCookies | Other | Hige dose, Medium dose, Placebo, low dosage |
Primary outcome
POP (plant sterol oxidation products) value
Time frame: 0 to 42 days
To estimate the change from baseline in serum POP concentration after intake of various POP doses.
2 secondary outcomes
COP (cholesterol oxidation products) value
Time frame: 0 to 42 days
Ratio of serum POP concentration
Time frame: 0 to 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Keicher, Dr principal investigator
Charité Research Organisation GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cookies enriched with POP in people with Healthy, run by Unilever R&D at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POP (plant sterol oxidation products) value (time frame: 0 to 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.