Skip to content

Citrulline and Protein Metabolism in the Malnourished Elderly People

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00714675
Acronym
CIPROAGE
Enrollment
27
Registered
2008-07-14
Start date
2009-12-31
Completion date
2013-01-31
Last updated
2013-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism, Elderly

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTCitrulline

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

DIETARY_SUPPLEMENTAmino 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
clinical toleranceEvery day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026