NCT00714675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

3.1 years

First QC Date

July 11, 2008

Last Update Submit

December 29, 2013

Conditions

MetabolismElderly

Keywords

citrullineprotein-energy malnutritionagedprotein biosynthesisamino acid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • clinical tolerance

    Every day

Study Arms (2)

1

EXPERIMENTAL

Citrulline

Dietary Supplement: Citrulline

2

ACTIVE COMPARATOR

Amino acids

Dietary Supplement: Amino acids

Interventions

CitrullineDIETARY_SUPPLEMENT

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

1
Amino acidsDIETARY_SUPPLEMENT

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.

2

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Emile Roux

Limeil-Brévannes, 94, France

Location

Related Publications (2)

  • 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.

    PMID: 17953788BACKGROUND

  • 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.

    PMID: 16608884BACKGROUND

MeSH Terms

Conditions

Protein-Energy Malnutrition

Interventions

CitrullineAmino Acids

Condition Hierarchy (Ancestors)

Protein DeficiencyDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, DiaminoAmino Acids, Peptides, and Proteins

Study Officials

  • Jean-Claude Melchior

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 14, 2008

Study Start

December 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

FR(1)