HyperlipidemiaPSE-MONCT00928616
Differential Effects of a Diet Supplementation With Plant Sterol Esters on Human Monocytes
A study testing margarine + plant sterol esters in people with Hyperlipidemia, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- margarine + plant sterol esters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Jun 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals without known cardiovascular diseases
Who cannot join
- drugs that interfere with cholesterol metabolism
- other use of dietary supplements
- vegetarianism
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Homburg, Saarland, 66421
About this study
Official title: Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.
The purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.
Read the detailed description
This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.
- Conditions
- Hyperlipidemia
- Being tested
- margarine + plant sterol esters, margarine (placebo)
- Keywords
- hyperlipidemia, plant sterols, monocytes
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
margarine + plant sterol estersDietary supplement
Also called plant sterols
margarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks
margarine (placebo)Dietary supplement
Also called regular margarine
non-sterol ester supplemented margarine
| Study group | Role | What they receive |
|---|---|---|
| plant sterol esters | Experimental | Participants consume plant sterol ester supplemented margarine (3 g/day) Receives: Dietary Supplement: margarine + plant sterol esters |
| Placebo | Placebo comparator | Placebo is a non-sterol ester supplemented margarine Receives: Dietary Supplement: margarine (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocyte subpopulations
Measured: 4 weeks
Secondary outcomes (1)
serum parameters (lipids, plant sterol concentrations, inflammation parameters)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Investigators
- Oliver Weingärtner, MD, Principal investigator, Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928616
- Sponsor's protocol ID
- 108/07
- Other IDs
- 108/07
- Acronym
- PSE-MO
- Status last verified
- Jun 2009
- First submitted
- 25 Jun 2009
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of "Functional Foods" Supplemented With Plant Sterol Esters on Blood Cells and Serum Parameters.
- ClinicalTrials.gov ID
- NCT00928616
- Acronym / sponsor ID
- PSE-MO / 108/07
- Conditions
- Hyperlipidemia
- Keywords
- hyperlipidemia, plant sterols, monocytes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 26 Jun 2009 (estimated)
- 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 purpose of this study is to evaluate the effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.
Detailed description
This study investigates effects of a diet supplementation with plant sterol esters on serum lipids, plant sterol concentrations and monocyte subpopulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plant sterol esters | Experimental | Dietary Supplement: margarine + plant sterol estersParticipants consume plant sterol ester supplemented margarine (3 g/day) |
| Placebo | Placebo comparator | Dietary Supplement: margarine (placebo)Placebo is a non-sterol ester supplemented margarine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy individuals without known cardiovascular diseases
Key exclusion criteria (3 listed)
- drugs that interfere with cholesterol metabolism
- other use of dietary supplements
- vegetarianism
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 |
|---|---|---|
| margarine + plant sterol estersAlso: plant sterolsmargarine supplemented with plant sterol esters (3g/day) over the time period of 4 weeks | Dietary supplement | plant sterol esters |
| margarine (placebo)Also: regular margarinenon-sterol ester supplemented margarine | Dietary supplement | Placebo |
Primary outcome
monocyte subpopulations
Time frame: 4 weeks
1 secondary outcome
serum parameters (lipids, plant sterol concentrations, inflammation parameters)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
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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.
Oliver Weingärtner, MD principal investigator
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing margarine + plant sterol esters in people with Hyperlipidemia, run by University Hospital, Saarland 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jun 2009. 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?
Results are not available in the source record.
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?
monocyte subpopulations (time frame: 4 weeks). 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 26 Jun 2009.