GastrointestinalNCT01239303
Effects of Citrulline on Gut Functioning During Excercise
A study testing Citrulline and alanine in people with Gastrointestinal and Hypoperfusion, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy individuals. Improving the availability of NO might result increase splanchnic perfusion and prevent organ damage during exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal, Hypoperfusion, Gut Damage
- What is being tested?
- Citrulline and alanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to Feb 2012
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- age 18-35 years
Who cannot join
- not healthy
- use of medication or related products
- alcohol misuse
- smoking
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
About this study
During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy individuals. Improving the availability of NO might result increase splanchnic perfusion and prevent organ damage during exercise.
Read the detailed description
The gastrointestinal (GI) tract plays an important role in the human body. The wall of the GI system regulates digestion and absorption of nutrients and it also has a very important function as a barrier between internal and external environment. The penetration of harmful substances and microbiota of the GI lumen (external environment) to the systemic circulation (internal environment) depends on this barrier. Previous studies have shown that exercise in healthy subjects provides hypoperfusion of the splanchnic area, resulting in intestinal damage, increased small intestinal permeability and liver damage. Similar splanchnic hypoperfusion occurs in patients with compromised circulation.
During episodes of splanchnic hypoperfusion, the de novo synthesis of nitric oxide (nitric oxide, NO) from arginine is compromised. This impaired NO synthesis may play a role in the development of organ dysfunction during exercise. L-citrulline administration, a precursor of arginine and NO, may result in improved NO availability and organ perfusion, thereby preventing organ damage.
- Conditions
- Gastrointestinal, Hypoperfusion, Gut Damage
- Being tested
- Citrulline, alanine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitrullineDietary supplement
single dose
alanineDietary supplement
single dose
| Study group | Role | What they receive |
|---|---|---|
| citrulline | Active comparator | Not described Receives: Dietary Supplement: Citrulline |
| alanine | Placebo comparator | Not described Receives: Dietary Supplement: alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI perfusion
Measured: 2 hours
gut damage
Measured: 5 hours
microcirculation
Measured: 5 hours
Secondary outcomes (3)
liver damage
Measured: 5 hours
kidney damage
Measured: 5 hours
amino acid analysis
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrointestinalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Principal investigator, Kim van Wijck, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239303
- Sponsor's protocol ID
- MEC10-3-064
- Status last verified
- Nov 2011
- First submitted
- 10 Nov 2010
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Citrulline on Gut Functioning During Excercise
- ClinicalTrials.gov ID
- NCT01239303
- Acronym / sponsor ID
- MEC10-3-064
- Conditions
- Gastrointestinal, Hypoperfusion, Gut Damage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Dec 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 11 Nov 2010 (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.
During exercise, splanchnic perfusion is compromised, resulting in organ damage in healthy individuals. Improving the availability of NO might result increase splanchnic perfusion and prevent organ damage during exercise.
Detailed description
The gastrointestinal (GI) tract plays an important role in the human body. The wall of the GI system regulates digestion and absorption of nutrients and it also has a very important function as a barrier between internal and external environment. The penetration of harmful substances and microbiota of the GI lumen (external environment) to the systemic circulation (internal environment) depends on this barrier. Previous studies have shown that exercise in healthy subjects provides hypoperfusion of the splanchnic area, resulting in intestinal damage, increased small intestinal permeability and liver damage. Similar splanchnic hypoperfusion occurs in patients with compromised circulation.
During episodes of splanchnic hypoperfusion, the de novo synthesis of nitric oxide (nitric oxide, NO) from arginine is compromised. This impaired NO synthesis may play a role in the development of organ dysfunction during exercise. L-citrulline administration, a precursor of arginine and NO, may result in improved NO availability and organ perfusion, thereby preventing organ damage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| citrulline | Active comparator | Dietary Supplement: Citrulline |
| alanine | Placebo comparator | Dietary Supplement: alanine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male
- age 18-35 years
Key exclusion criteria (4 listed)
- not healthy
- use of medication or related products
- alcohol misuse
- smoking
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 |
|---|---|---|
| Citrullinesingle dose | Dietary supplement | citrulline |
| alaninesingle dose | Dietary supplement | alanine |
Primary outcome
GI perfusion
Time frame: 2 hours
gut damage
Time frame: 5 hours
microcirculation
Time frame: 5 hours
3 secondary outcomes
liver damage
Time frame: 5 hours
kidney damage
Time frame: 5 hours
amino acid analysis
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrulline and alanine in people with Gastrointestinal and Hypoperfusion, 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 4 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 8 Nov 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 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. 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?
GI perfusion (time frame: 2 hours). The study lists 3 primary outcomes in all. 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 8 Nov 2011.