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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kyowa Hakko Kogyo (Japan) providing the amino acids
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00714675
First received: July 11, 2008
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Metabolism
Elderly
 Dietary Supplement: Citrulline
Dietary Supplement: Amino acids

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Citrulline Supplementation in Elderly Malnourished and Hospitalised Subjects: Effects on Protein Metabolism

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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) [ Time Frame: after 3 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical tolerance [ Time Frame: Every day ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: December 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Citrulline
 Dietary Supplement: Citrulline
1 unit of 10 g L-Citrulline, 1 time on morning during 21 days
Other Name: Citrulline
Active Comparator: 2
Amino acids
 Dietary Supplement: 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.
Other Name: Amino acids

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714675

Locations
France
Hôpital Emile Roux
Limeil-Brevannes, France, 94
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Kyowa Hakko Kogyo (Japan) providing the amino acids
Investigators
Principal Investigator: Jean-Claude Melchior Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00714675     History of Changes
Other Study ID Numbers: P070127
Study First Received: July 11, 2008
Last Updated: November 21, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
citrulline
protein-energy malnutrition
aged
protein biosynthesis
amino acid

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 23, 2013