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

NCT ID: NCT00756080

Last Updated: 2010-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-01-31

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 .

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

After receiving a 7-day oral supplementation with citrulline, each subject will be admitted to the Clinical Investigation Unit for a half day, after an overnight fast,and will receive a 5-h intravenous infusion of L-\[1-13C\]leucine (i.e.; leucine labeled with 13C, a stable isotope of carbon) from 8 am to 1 pm. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, the keto acid of leucine, using gas chromatography-mas spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. The subject will then leave the hospital, take no treatment for13 days (wash-out period). The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with placebo, as a cross-over study design will be used.

Group Type: EXPERIMENTAL

citrulline

Intervention Type: DRUG

0.06 G/kg three times/day during 7 days

2

After receiving a 7-day oral supplementation with placebo, each subject will be admitted to the Clinical Investigation Unit for a half day, after an overnight fast,and will receive a 5-h intravenous infusion of L-\[1-13C\]leucine (i.e.; leucine labeled with 13C, a stable isotope of carbon) from 8 am to 1 pm. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, the keto acid of leucine, using gas chromatography-mas spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. The subject will then leave the hospital, take no treatment for13 days (wash-out period). The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with citrulline, as a cross-over study design will be used.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

citrulline

0.06 G/kg three times/day during 7 days

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nantes University Hospital

Principal Investigators

Dominique Darmaun, Professor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Ronan THIBAULD, Doctor

Role: STUDY_CHAIR

Nantes University Hospital

Locations

CHU Nantes

Nantes, , France

Countries

France

Other Identifiers

BRD 07/12-D

Identifier Type: -

Identifier Source: org_study_id