Citrulline and Protein Metabolism in the Malnourished Elderly People

Study Overview
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Brief Summary
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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
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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.

Official Title
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Citrulline Supplementation in Elderly Malnourished and Hospitalised Subjects: Effects on Protein Metabolism

Conditions
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Metabolism, Elderly

Intervention / Treatment
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* Dietary Supplement: Citrulline
* Dietary Supplement: Amino acids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Citrulline | Dietary Supplement: Citrulline<br>* 1 unit of 10 g L-Citrulline, 1 time on morning during 21 days<br>|
| Active Comparator: 2<br>Amino acids | Dietary Supplement: Amino acids<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | after 3 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical tolerance |  | Every day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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citrulline, protein-energy malnutrition, aged, protein biosynthesis, amino acid