IleostomaSTOMANCT00846937
Plant Stanol Ester Beverage and Ileostoma Patients
A study testing Plant stanolester and fatty acid in people with Ileostoma, run by University of Helsinki at 1 site in Finland.
Trial summary
We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester beverage with or without a fatty acid… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostoma
- What is being tested?
- Plant stanolester and fatty acid
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2009to May 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy proctocolectomized subjects with an ileostoma
Who cannot join
- Chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Plant Stanolester Beverage on Cholesterol Metabolism Among Human Subjects With Ileostoma
We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester beverage with or without a fatty acid preparation in a random order for one week period after a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids, sterols and fecal sterols and variables of cholesterol metabolism will be examined accordingly.
- Conditions
- Ileostoma
- Being tested
- Plant stanolester and fatty acid
- Keywords
- Cholesterol, Plant stanolester, Beverage, Ileostoma, Serum cholesterol level, serum LDL-cholesterol level, Intestinal cholesterol absorption efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant stanolester and fatty acidDietary supplement
Plant stanol ester 2gr/day and fatty acid in a beverage compared to plant stanol ester 2gr /day and placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cholesterol level
Measured: After treatment perdiods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleostomaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Investigators
- Markku J. Nissinen, MD,PhD, Principal investigator, University of HelsinkiTatu Miettinen, Professor, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846937
- Sponsor's protocol ID
- 3097
- Other IDs
- U1010G0020
- Acronym
- STOMA
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Plant Stanolester Beverage on Cholesterol Metabolism Among Human Subjects With Ileostoma
- ClinicalTrials.gov ID
- NCT00846937
- Acronym / sponsor ID
- STOMA / 3097
- Conditions
- Ileostoma
- Keywords
- Cholesterol, Plant stanolester, Beverage, Ileostoma, Serum cholesterol level, serum LDL-cholesterol level, Intestinal cholesterol absorption efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Feb 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.
We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester beverage with or without a fatty acid preparation in a random order for one week period after a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids, sterols and fecal sterols and variables of cholesterol metabolism will be examined accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy proctocolectomized subjects with an ileostoma
Key exclusion criteria (1 listed)
- Chronic illness
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 |
|---|---|---|
| Plant stanolester and fatty acidPlant stanol ester 2gr/day and fatty acid in a beverage compared to plant stanol ester 2gr /day and placebo | Dietary supplement | – |
Primary outcome
serum cholesterol level
Time frame: After treatment perdiods
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 10 Feb 2011.
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RecruitingObservational study
Magnesium in Gastrointestinal Disease
Colitis Ulcerosa, Colitis Ulcerative
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.
Markku J. Nissinen, MD,PhD principal investigator
University of Helsinki
Tatu Miettinen, Professor study director
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant stanolester and fatty acid in people with Ileostoma, run by University of Helsinki at 1 site in Finland.
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 1 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 10 Feb 2011. 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 Finland. 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. 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?
serum cholesterol level (time frame: After treatment perdiods). 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 10 Feb 2011.