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

Nantes University Hospital11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Intestinal Failure

Interventions

Citrulline and placeboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Nantes University Hospital

Nantes, France

Clinique Saint Yves

Rennes, France

Outcomes

Primary Outcomes

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 Outcomes

nitrogen balance

Using a 6-h urine collection, to determine the effect of oral citrulline administration on nitrogen balance

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

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.

Data from ClinicalTrials.gov

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