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Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2) (CITRUGRELE 2)

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ClinicalTrials.gov Identifier: NCT01386034
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. The investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis.

Condition or disease Intervention/treatment Phase
Intestinal Failure Drug: Citrulline and placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure : a Prospective, Randomized, Double-blind, Cross-over Study
Study Start Date : July 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Citrulline/Placebo Drug: Citrulline and placebo
After receiving a 7-day oral supplementation with either citrulline or placebo, each subject will be admitted for a half day, after an overnight fast, and will receive a 5-h intravenous infusion of L-[1-13C]leucine. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, using gas chromatography-mass spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. Then the subject take no treatment for 13 days. The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with either citrulline or placebo.

Experimental: Placebo/Citrulline Drug: Citrulline and placebo
After receiving a 7-day oral supplementation with either citrulline or placebo, each subject will be admitted for a half day, after an overnight fast, and will receive a 5-h intravenous infusion of L-[1-13C]leucine. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, using gas chromatography-mass spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. Then the subject take no treatment for 13 days. The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with either citrulline or placebo.




Primary Outcome Measures :
  1. whole body protein synthesis
    To determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal insufficiency, as measured using an intravenous infusion of stable isotope labelled leucine.


Secondary Outcome Measures :
  1. nitrogen balance
    Using a 6-h urine collection, to determine the effect of oral citrulline administration on nitrogen balance

  2. Measure of insulin
    to determine whether the putative protein anabolic effect of citrulline is mediated by insulin or insulin-like-growth factor 1 (IGF-1), based on measurement of their plasma concentrations

  3. Measure of insulin-like-growth factor 1 (IGF-1)
    To determine whether the putative protein anabolic effect of citrulline is mediated by insulin or insulin-like-growth factor 1 (IGF-1), based on measurement of their plasma concentrations.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult between 18 and 75 years
  • Patient with short bowel syndrome
  • Patient with an incompetent small intestine after intestinal resection
  • Patient fed orally and beyond more than 6 weeks after surgery
  • Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol®
  • No current artificial feeding (parenteral)
  • No low-sodium diet- No renal, cardiac, respiratory or hepatic insufficiency
  • No chronic inflammatory disease (intestinal or other)
  • No current corticosteroid treatment
  • Fasting blood glucose below 6mmol/L
  • Patient able to understand benefits and risks of protocol
  • Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 15 days following the end of the study
  • Signed informed consent

Exclusion Criteria:

  • Subject not fulfilling inclusion criteria
  • Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique"
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386034


Locations
France
Nantes University Hospital
Nantes, France
Clinique Saint Yves
Rennes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Dominique DARMAUN, Pr Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01386034     History of Changes
Other Study ID Numbers: BRD/09/05-W
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: May 2016

Keywords provided by Nantes University Hospital:
Nutrition, protein metabolism, stable isotopes, mass spectrometry, intestinal failure