Transduction PathwayIntesmetaproNCT01254110
Amino Acid and Intestinal Protein Metabolism : Working Study
An observational study of Transduction Pathway and Proteinic Synthesis, run by University Hospital, Rouen at 1 site in France.
Trial summary
Gut protein metabolism that could be influenced by protein supply is involved in the regulation of several physiological functions such as gut barrier function and represents a major contribution in the whole-body protein turnover. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Transduction Pathway, Proteinic Synthesis, Proteolytic System
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Feb 2012
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers
Who may be able to join
- volunteers with seronegativity for HIV1 and HIV2 and HCV and HVB
- good nutritional state with physical indication mass included between 18,5 and 25kg/m2
- non-smoking volunteers
- volunteers without digestive, allergic or haemorrhagic history
- volunteers without progressive disease
- digestive endoscopy tolerance
- age >=18 and <= 50years
- consent obtained from volunteers
Who cannot join
- smoking volunteers
- volunteers with digestive, or allergic history
- volunteers with haemorrhagic sign
- pregnancy
- progressive digestive disease
- significant progressive disease
Show all 9Show fewer
- volunteers with therapeutic treatment (aspirin)
- digestive endoscopy intolerance
- volunteers with neurological disorder or with delicate psychological state
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique - Hôpital charles Nicolle
Rouen, Seine maritime, 76031
About this study
Official title: Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism
Gut protein metabolism that could be influenced by protein supply is involved in the regulation of several physiological functions such as gut barrier function and represents a major contribution in the whole-body protein turnover. Intracellular pathways implicated in the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of the present project is to evaluate and to understand the effects of amino acids (glutamine, leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Enterally fed with leucine | |
| 2 | Enterally fed with glutamine | |
| 3 | Enterally fed with protein powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy
Measured: 18 months
Secondary outcomes (3)
Assessment of involved signaling pathways
Measured: 18 months
Assessment of intestinal proteolysis
Measured: 18 months
Assessment of protein synthesis rate in intestinal mitochondria
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startApr 2009
- Primary completionJan 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transduction PathwayStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moise COEFFIER, Study chair, UH RouenAnne-Françoise CAILLEUX, Doctor, Study chair, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254110
- Sponsor's protocol ID
- 2007/142/HP
- Other IDs
- ID RCB 2008-A00692-53
- Acronym
- Intesmetapro
- Status last verified
- Oct 2013
- First submitted
- 9 Mar 2009
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Goichon A, Bertrand J, Chan P, Lecleire S, Coquard A, Cailleux AF, Vaudry D, Dechelotte P, Coeffier M. Enteral delivery of proteins enhances the expression of proteins involved in the cytoskeleton and protein biosynthesis in human duodenal mucosa. Am J Clin Nutr. 2015 Aug;102(2):359-67. doi: 10.3945/ajcn.114.104216. Epub 2015 Jun 24.
PubMed 26109581Bertrand J, Goichon A, Chan P, Azhar S, Lecleire S, Donnadieu N, Vaudry D, Cailleux AF, Dechelotte P, Coeffier M. Enteral glutamine infusion modulates ubiquitination of heat shock proteins, Grp-75 and Apg-2, in the human duodenal mucosa. Amino Acids. 2014 Apr;46(4):1059-67. doi: 10.1007/s00726-014-1670-x. Epub 2014 Jan 22.
PubMed 24449167Coeffier M, Claeyssens S, Bole-Feysot C, Guerin C, Maurer B, Lecleire S, Lavoinne A, Donnadieu N, Cailleux AF, Dechelotte P. Enteral delivery of proteins stimulates protein synthesis in human duodenal mucosa in the fed state through a mammalian target of rapamycin-independent pathway. Am J Clin Nutr. 2013 Feb;97(2):286-94. doi: 10.3945/ajcn.112.046946. Epub 2013 Jan 2.
PubMed 23283505Coeffier M, Claeyssens S, Bensifi M, Lecleire S, Boukhettala N, Maurer B, Donnadieu N, Lavoinne A, Cailleux AF, Dechelotte P. Influence of leucine on protein metabolism, phosphokinase expression, and cell proliferation in human duodenum1,3. Am J Clin Nutr. 2011 Jun;93(6):1255-62. doi: 10.3945/ajcn.111.013649. Epub 2011 Apr 20.
PubMed 21508089
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study on Glutamine and Leucine Effects on Intestinal Protein Metabolism
- ClinicalTrials.gov ID
- NCT01254110
- Acronym / sponsor ID
- Intesmetapro / 2007/142/HP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Dec 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.
Gut protein metabolism that could be influenced by protein supply is involved in the regulation of several physiological functions such as gut barrier function and represents a major contribution in the whole-body protein turnover. Intracellular pathways implicated in the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of the present project is to evaluate and to understand the effects of amino acids (glutamine, leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Enterally fed with leucine |
| 2 | – | –Enterally fed with glutamine |
| 3 | – | –Enterally fed with protein powder |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers
Key inclusion criteria (8 listed)
- volunteers with seronegativity for HIV1 and HIV2 and HCV and HVB
- good nutritional state with physical indication mass included between 18,5 and 25kg/m2
- non-smoking volunteers
- volunteers without digestive, allergic or haemorrhagic history
- volunteers without progressive disease
Key exclusion criteria (9 listed)
- smoking volunteers
- volunteers with digestive, or allergic history
- volunteers with haemorrhagic sign
- pregnancy
- progressive digestive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy
Time frame: 18 months
3 secondary outcomes
Assessment of involved signaling pathways
Time frame: 18 months
Assessment of intestinal proteolysis
Time frame: 18 months
Assessment of protein synthesis rate in intestinal mitochondria
Time frame: 18 months
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 16 Oct 2013.
- Derived from this study: PubMed 26109581Goichon A, Bertrand J, Chan P, Lecleire S, Coquard A, Cailleux AF, Vaudry D, Dechelotte P, Coeffier M. Enteral delivery of proteins enhances the expression of proteins involved in the cytoskeleton and protein biosynthesis in human duodenal mucosa. Am J Clin Nutr. 2015 Aug;102(2):359-67. doi: 10.3945/ajcn.114.104216. Epub 2015 Jun 24.
- Derived from this study: PubMed 24449167Bertrand J, Goichon A, Chan P, Azhar S, Lecleire S, Donnadieu N, Vaudry D, Cailleux AF, Dechelotte P, Coeffier M. Enteral glutamine infusion modulates ubiquitination of heat shock proteins, Grp-75 and Apg-2, in the human duodenal mucosa. Amino Acids. 2014 Apr;46(4):1059-67. doi: 10.1007/s00726-014-1670-x. Epub 2014 Jan 22.
- Derived from this study: PubMed 23283505Coeffier M, Claeyssens S, Bole-Feysot C, Guerin C, Maurer B, Lecleire S, Lavoinne A, Donnadieu N, Cailleux AF, Dechelotte P. Enteral delivery of proteins stimulates protein synthesis in human duodenal mucosa in the fed state through a mammalian target of rapamycin-independent pathway. Am J Clin Nutr. 2013 Feb;97(2):286-94. doi: 10.3945/ajcn.112.046946. Epub 2013 Jan 2.
- Derived from this study: PubMed 21508089Coeffier M, Claeyssens S, Bensifi M, Lecleire S, Boukhettala N, Maurer B, Donnadieu N, Lavoinne A, Cailleux AF, Dechelotte P. Influence of leucine on protein metabolism, phosphokinase expression, and cell proliferation in human duodenum1,3. Am J Clin Nutr. 2011 Jun;93(6):1255-62. doi: 10.3945/ajcn.111.013649. Epub 2011 Apr 20.
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.
Moise COEFFIER study chair
UH Rouen
Anne-Françoise CAILLEUX, Doctor study chair
UH Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transduction Pathway and Proteinic Synthesis, run by University Hospital, Rouen at 1 site in France.
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 8 inclusion and 9 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 16 Oct 2013. 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 France. 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?
assessment of intestinal protein synthesis stimulation by Leucine or glutamine in duodenal biopsy (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01254110, which also lists 4 linked publications.
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 16 Oct 2013.