Citrulline and Protein Metabolism in the Malnourished Elderly People
NCT ID: NCT00714675
Last Updated: 2013-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
27 participants
INTERVENTIONAL
2009-12-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Citrulline
Citrulline
1 unit of 10 g L-Citrulline, 1 time on morning during 21 days
2
Amino acids
Amino acids
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Citrulline
1 unit of 10 g L-Citrulline, 1 time on morning during 21 days
Amino acids
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* C reactive protein (CRP) \> 50 mg / l
* end-stage cardiac insufficiency
* severe digestive incapacity
* renal insufficiency (Creatinine Clearance \< 30 ml / mn)
* respiratory failure
* 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
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kyowa Hakko Kogyo (Japan) providing the amino acids
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Claude Melchior
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Emile Roux
Limeil-Brévannes, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Osowska 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P070127
Identifier Type: -
Identifier Source: org_study_id