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Completed

NCT Number: NCT00714675

Citrulline and Protein Metabolism in the Malnourished Elderly People

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Emile Roux

Limeil-Brévannes, 94, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citrulline

Dietary Supplement

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

Amino acids

Dietary 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.

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)

    Time frame: after 3 weeks of treatment

Secondary outcomes

  1. clinical tolerance

    Time frame: Every day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Kyowa Hakko Kogyo (Japan) providing the amino acids

Registry information

Official study title

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

Acronym: CIPROAGE

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2008
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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