Clinical trial NCT00756080: "Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study" (Citrugrêle)
Official title: "Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in healthy humans in the postabsorptive state. 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 .


Eligibility criteria: Inclusion Criteria:

* Healthy adult between 18 and 45 years of age
* Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol®
* Absence of any treatment with anabolic agents during the month prior to inclusion in the study- No current artificial feeding (enteral or parenteral)
* No renal, cardiac, respiratory or hepatic insufficiency
* No chronic inflammatory disease (intestinal or other
* No current corticotherapy
* Fasting blood glucose below 6mmol/L (126 mg/dL)
* Body mass index between 19 and 24.9
* Patient able to understand benefits and risks of protocol
* Not pregnant, taking oral contraceptive measure if able to procreate
* Subject affiliated to French health insurance (Sécurité Sociale)
* Informed consent form signed
* No concomitant participation to another clinical trial, and compliance with the exclusion period required by law

Exclusion Criteria:

* Subject not fulfilling inclusion criteria
* Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique"
* Subject for whom the participation in this clinical trial would result, by cumulating stipends received for other clinical trials, in earning more than 4500 € within 12 consecutive months

Primary outcomes:
measure: To determine whether oral citrulline administration enhances whole body protein synthesis in healthy humans in the psotabsorptive state, as measured using an intravenous infusion of stable isotope labeled leucine
Secondary outcomes:
measure: Using a 12-h urine collection, to confirm the positive effect of oral citrulline administration on nitrogen balance observed in preliminary studies (Rougé et al, Am J Physiol 293:G1061, 2007)
measure: 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
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Dominique Darmaun, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Ronan THIBAULD, Doctor
role: STUDY_CHAIR
References: