Citrulline and Protein Metabolism in the Malnourished Elderly People (CIPROAGE)
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|ClinicalTrials.gov Identifier: NCT00714675|
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : December 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metabolism Elderly||Dietary Supplement: Citrulline Dietary Supplement: Amino acids||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Citrulline Supplementation in Elderly Malnourished and Hospitalised Subjects: Effects on Protein Metabolism|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Dietary Supplement: Citrulline
1 unit of 10 g L-Citrulline, 1 time on morning during 21 days
Active Comparator: 2
Dietary Supplement: 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.
- 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 ]
- clinical tolerance [ Time Frame: Every day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714675
|Hôpital Emile Roux|
|Limeil-Brevannes, France, 94|
|Principal Investigator:||Jean-Claude Melchior||Assistance Publique - Hôpitaux de Paris|