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
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