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

Nantes University Hospital12 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Subjects

Interventions

citrullineDRUG

0.06 G/kg three times/day during 7 days

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHU Nantes

Nantes, France

Outcomes

Primary Outcomes

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

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)

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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