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

Phase 3

Completed

• Conditions: Intestinal Failure
• Interventions: Drug: Citrulline and placebo

• Registration Number: NCT01386034
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2012-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-05
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Citrulline/Placebo	Citrulline and placebo	-
Placebo/Citrulline	Citrulline and placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Nantes University Hospital; 🇫🇷 Nantes, France

Clinique Saint Yves; 🇫🇷 Rennes, France