MetabolismCIPROAGENCT00714675
Citrulline and Protein Metabolism in the Malnourished Elderly People
A study testing Citrulline and Amino acids in people with Metabolism and Elderly, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to evaluate the effects of a supplementation of citrulline for three weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Metabolism, Elderly
- What is being tested?
- Citrulline and Amino acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Jan 2013
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elderly hospitalised in geriatric medicine or in following care and rehabilitation, moderately malnourished
- aged more than 70 years
- recent moderate undernutrition (30 g/l < albuminemia < 35 g/l and 18 < BMI < 22 or a score of the Mini Nutritional Assessment (MNA) < 17 with albuminemia > 30 g/l)
- ingesta of at least 20 kcal / kg / d and 0,8 g / kg / d of proteins
Who cannot join
- hospitalisation < 21d
- C reactive protein (CRP) > 50 mg / l
- end-stage cardiac insufficiency
- severe digestive incapacity
- renal insufficiency (Creatinine Clearance < 30 ml / mn)
- respiratory failure
Show all 15Show fewer
- MMS < 18
- uncontrolled acute or chronic infectious pathology (HIV, tuberculosis)
- corticoids treatment
- evolutionary neoplasia
- palliative phase of severe pathology
- Mental Mini Score status of Folstein (MMS) < 8
- parenteral nutrition
- active chronic hepatitis or cirrhosis
- participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Citrulline Supplementation in Elderly Malnourished and Hospitalised Subjects: Effects on Protein Metabolism
The aim of this study is to evaluate the effects of a supplementation of citrulline for three weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis.
Read the detailed description
Malnutrition in the elderly causes an important public health problem because their response to re nutrition is highly decreased. Several experimental studies have shown that an amino acid named citrulline could avoid this, by restoring protein synthesis.
The treated group will receive each morning for three weeks a supplementation of 10 g of citrulline and the control group, non essential amino acids in iso-nitrogenous quantity to the 10g of citrulline.
During the three weeks of supplementation, clinical tolerance and physical exercise will be evaluated regularly.
On the 21st day, whole body protein synthesis rate in the post-absorptive state will be measured by the isotopic dilution of L-leucine (1-13C expressed in g / kg of lean mass / 24h) as well as other parameters of the protein turn-over in the post-absorptive and post-prandial state.
- Conditions
- Metabolism, Elderly
- Being tested
- Citrulline, Amino acids
- Keywords
- citrulline, protein-energy malnutrition, aged, protein biosynthesis, amino acid
- Medical subject headings
- Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitrullineDietary supplement
1 unit of 10 g L-Citrulline, 1 time on morning during 21 days
Amino acidsDietary supplement
1 unit of an equivalent quantity of iso nitrogenous of non-essential amino acids(alanine, aspartate, glycine, serine, histidine, proline), 1 time on morning during 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Citrulline Receives: Dietary Supplement: Citrulline |
| 2 | Active comparator | Amino acids Receives: Dietary Supplement: Amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body protein synthesis rate in the post-absorptive state measured by the isotopic dilution of L-leucine (1-13C expressed in g / kg of lean mass / 24h)
Measured: after 3 weeks of treatment
Secondary outcomes (1)
clinical tolerance
Measured: Every day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startDec 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Hakko Kogyo (Japan) providing the amino acids
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Melchior, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714675
- Sponsor's protocol ID
- P070127
- Acronym
- CIPROAGE
- Status last verified
- Dec 2013
- First submitted
- 11 Jul 2008
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moinard C, Nicolis I, Neveux N, Darquy S, Benazeth S, Cynober L. Dose-ranging effects of citrulline administration on plasma amino acids and hormonal patterns in healthy subjects: the Citrudose pharmacokinetic study. Br J Nutr. 2008 Apr;99(4):855-62. doi: 10.1017/S0007114507841110. Epub 2007 Oct 22.
PubMed 17953788Osowska S, Duchemann T, Walrand S, Paillard A, Boirie Y, Cynober L, Moinard C. Citrulline modulates muscle protein metabolism in old malnourished rats. Am J Physiol Endocrinol Metab. 2006 Sep;291(3):E582-6. doi: 10.1152/ajpendo.00398.2005. Epub 2006 Apr 11.
PubMed 16608884
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citrulline Supplementation in Elderly Malnourished and Hospitalised Subjects: Effects on Protein Metabolism
- ClinicalTrials.gov ID
- NCT00714675
- Acronym / sponsor ID
- CIPROAGE / P070127
- Conditions
- Metabolism, Elderly
- Keywords
- citrulline, protein-energy malnutrition, aged, protein biosynthesis, amino acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Kyowa Hakko Kogyo (Japan) providing the amino acids
- Study start
- Dec 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Jul 2008 (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 aim of this study is to evaluate the effects of a supplementation of citrulline for three weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis.
Detailed description
Malnutrition in the elderly causes an important public health problem because their response to re nutrition is highly decreased. Several experimental studies have shown that an amino acid named citrulline could avoid this, by restoring protein synthesis.
The treated group will receive each morning for three weeks a supplementation of 10 g of citrulline and the control group, non essential amino acids in iso-nitrogenous quantity to the 10g of citrulline.
During the three weeks of supplementation, clinical tolerance and physical exercise will be evaluated regularly.
On the 21st day, whole body protein synthesis rate in the post-absorptive state will be measured by the isotopic dilution of L-leucine (1-13C expressed in g / kg of lean mass / 24h) as well as other parameters of the protein turn-over in the post-absorptive and post-prandial state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: CitrullineCitrulline |
| 2 | Active comparator | Dietary Supplement: Amino acidsAmino acids |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- elderly hospitalised in geriatric medicine or in following care and rehabilitation, moderately malnourished
- aged more than 70 years
- recent moderate undernutrition (30 g/l < albuminemia < 35 g/l and 18 < BMI < 22 or a score of the Mini Nutritional Assessment (MNA) < 17 with albuminemia > 30 g/l)
- ingesta of at least 20 kcal / kg / d and 0,8 g / kg / d of proteins
Key exclusion criteria (15 listed)
- hospitalisation < 21d
- C reactive protein (CRP) > 50 mg / l
- end-stage cardiac insufficiency
- severe digestive incapacity
- renal insufficiency (Creatinine Clearance < 30 ml / mn)
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 |
|---|---|---|
| Citrulline1 unit of 10 g L-Citrulline, 1 time on morning during 21 days | Dietary supplement | 1 |
| Amino acids1 unit of an equivalent quantity of iso nitrogenous of non-essential amino acids(alanine, aspartate, glycine, serine, histidine, proline), 1 time on morning during 21 days. | Dietary supplement | 2 |
Primary outcome
Whole body protein synthesis rate in the post-absorptive state measured by the isotopic dilution of L-leucine (1-13C expressed in g / kg of lean mass / 24h)
Time frame: after 3 weeks of treatment
1 secondary outcome
clinical tolerance
Time frame: Every day
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 Dec 2013.
- Background: PubMed 17953788Moinard C, Nicolis I, Neveux N, Darquy S, Benazeth S, Cynober L. Dose-ranging effects of citrulline administration on plasma amino acids and hormonal patterns in healthy subjects: the Citrudose pharmacokinetic study. Br J Nutr. 2008 Apr;99(4):855-62. doi: 10.1017/S0007114507841110. Epub 2007 Oct 22.
- Background: PubMed 16608884Osowska S, Duchemann T, Walrand S, Paillard A, Boirie Y, Cynober L, Moinard C. Citrulline modulates muscle protein metabolism in old malnourished rats. Am J Physiol Endocrinol Metab. 2006 Sep;291(3):E582-6. doi: 10.1152/ajpendo.00398.2005. Epub 2006 Apr 11.
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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.
Jean-Claude Melchior principal investigator
Assistance Publique - Hôpitaux de Paris
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 Amino acids in people with Metabolism and Elderly, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 15 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 Dec 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?
Whole body protein synthesis rate in the post-absorptive state measured by the isotopic dilution of L-leucine (1-13C expressed in g / kg of lean mass / 24h) (time frame: after 3 weeks of treatment). 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 NCT00714675, which also lists 2 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 31 Dec 2013.