"Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study" (Citrugrêle)

Healthy Subjects Clinical Trial

Official title:

"Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756080
• Other study ID #: BRD 07/12-D
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2008
• Last updated: March 8, 2010
• Start date: September 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• citrulline
0.06 G/kg three times/day during 7 days
• placebo
placebo (equimolar mixture of 6 non essential amino acids: alanine, aspartate, glycine, histidine, proline, serine) 0,006 g/kg 3 times/day during 7 days

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	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)			No
Secondary	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			No