TraumaEarly Phase 1NCT00468507
The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application
A Early Phase 1 study testing nutritional intervention with Respifor and Diasip in people with Trauma, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently our group demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates severe inflammation, gut barrier loss and hepatic… Read more about this study
- Who is it for?
- Ages 45 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- nutritional intervention with Respifor and Diasip
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2007to Mar 2010
- Phase
- Early Phase 1
- 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 45 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females
- 45 > age <55
Who cannot join
- Gastrointestinal diseases
- Inflammatory conditions
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently our group demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages via binding of acetylcholine to the alpha7-nicotinergic receptor.
In this study the cholecystokinin release in healthy volunteers is monitored in response to low fat and high fat food products.
- Conditions
- Trauma
- Being tested
- nutritional intervention with Respifor and Diasip
- Keywords
- CCK release
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional intervention with Respifor and DiasipDietary supplement
Four nutritional interventions on four separate days per test person
What is being measured
The primary outcome is the main question the study is designed to answer.
CCK-release
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startMar 2007
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jan-Willem Greve, professor, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468507
- Sponsor's protocol ID
- 067030
- Status last verified
- Mar 2010
- First submitted
- 1 May 2007
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application
- ClinicalTrials.gov ID
- NCT00468507
- Acronym / sponsor ID
- 067030
- Conditions
- Trauma
- Keywords
- CCK release
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 May 2007 (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.
Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently our group demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages via binding of acetylcholine to the alpha7-nicotinergic receptor.
In this study the cholecystokinin release in healthy volunteers is monitored in response to low fat and high fat food products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females
- 45 > age <55
Key exclusion criteria (2 listed)
- Gastrointestinal diseases
- Inflammatory conditions
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 |
|---|---|---|
| nutritional intervention with Respifor and DiasipFour nutritional interventions on four separate days per test person | Dietary supplement | – |
Primary outcome
CCK-release
Time frame: two hours
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 31 Mar 2010.
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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.
Jan-Willem Greve, professor principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing nutritional intervention with Respifor and Diasip in people with Trauma, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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 31 Mar 2010. 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 Netherlands. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
CCK-release (time frame: two hours). 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 31 Mar 2010.