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Citrulline and Protein Metabolism in the Malnourished Elderly People (CIPROAGE)

Primary Purpose

Metabolism, Elderly

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Citrulline

Amino acids

About this trial

This is an interventional treatment trial for Metabolism focused on measuring citrulline, protein-energy malnutrition, aged, protein biosynthesis, amino acid

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Emile Roux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Citrulline

Amino acids

Outcomes

Primary Outcome Measures

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 Measures

clinical tolerance

Full Information

NCT ID

NCT00714675

First Posted

July 11, 2008

Last Updated

December 29, 2013

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Kyowa Hakko Kogyo (Japan) providing the amino acids

1. Study Identification

Unique Protocol Identification Number

NCT00714675

Brief Title

Citrulline and Protein Metabolism in the Malnourished Elderly People

Acronym

CIPROAGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Kyowa Hakko Kogyo (Japan) providing the amino acids

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolism, Elderly

Keywords

citrulline, protein-energy malnutrition, aged, protein biosynthesis, amino acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Citrulline

Arm Title

Arm Type

Active Comparator

Arm Description

Amino acids

Intervention Type

Dietary Supplement

Intervention Name(s)

Citrulline

Intervention Description

1 unit of 10 g L-Citrulline, 1 time on morning during 21 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Amino acids

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

clinical tolerance

Time Frame

Every day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Claude Melchior

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Emile Roux

City

Limeil-Brevannes

ZIP/Postal Code

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

17953788

Citation

Moinard C, Nicolis I, Neveux N, Darquy S, Benazeth 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. doi: 10.1017/S0007114507841110. Epub 2007 Oct 22.

Results Reference

background

PubMed Identifier

16608884

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. doi: 10.1152/ajpendo.00398.2005. Epub 2006 Apr 11.

Results Reference

background

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Citrulline and Protein Metabolism in the Malnourished Elderly People

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