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Citrulline and Protein Metabolism in the Malnourished Elderly People

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metabolism; Elderly

Intervention: Citrulline (Dietary Supplement); Amino acids (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Jean-Claude Melchior, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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)

Secondary outcome: clinical tolerance

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.

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hôpital Emile Roux, Limeil-Brevannes 94, France
Additional Information

Related publications:

Moinard C, Nicolis I, Neveux N, Darquy S, Bénazeth 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. 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. Epub 2006 Apr 11.

Starting date: December 2009
Last updated: December 29, 2013

Page last updated: August 23, 2015

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