CIPROAGE: Citrulline and Protein Metabolism in the Malnourished Elderly People

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00714675

Collaborator

Kyowa Hakko Kogyo (Japan) providing the amino acids (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Elderly	Dietary Supplement: Citrulline Dietary Supplement: Amino acids	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Citrulline	Dietary Supplement: Citrulline 1 unit of 10 g L-Citrulline, 1 time on morning during 21 days
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.

Arm

Intervention/Treatment

Experimental: 1

Citrulline

Dietary Supplement: Citrulline

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

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.

Outcome Measures

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) [after 3 weeks of treatment]

Secondary Outcome Measures

clinical tolerance [Every day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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