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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01386034
• Date of registration: 24/06/2011
• Prospective Registration: Yes
• Primary sponsor: Nantes University Hospital
• Public title: Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2) CITRUGRELE 2
• Scientific title: Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure : a Prospective, Randomized, Double-blind, Cross-over Study
• Date of first enrolment: July 2012
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01386034
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Dominique DARMAUN, Pr
• Affiliation: Nantes University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Intestinal Failure

Intervention(s)

Drug: Citrulline and placebo

Primary Outcome(s)

whole body protein synthesis [Time Frame: 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(s)

nitrogen balance [Time Frame: Using a 6-h urine collection, to determine the effect of oral citrulline administration on nitrogen balance]

Measure of insulin-like-growth factor 1 (IGF-1) [Time Frame: 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 [Time Frame: 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]

Secondary ID(s)

BRD/09/05-W

Source(s) of Monetary Support

Please refer to primary and secondary sponsors