Citrulline and Protein Metabolism in the Malnourished Elderly People

Elderly Clinical Trial

— CIPROAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714675
• Other study ID #: P070127
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: December 29, 2013
• Start date: December 2009
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Elderly
• Metabolism

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
France	Hôpital Emile Roux	Limeil-Brevannes

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Kyowa Hakko Kogyo (Japan) providing the amino acids

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	clinical tolerance		Every day	Yes