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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00756080 |
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Date of registration:
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18/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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"Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study" (Citrugrêle)
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Scientific title:
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"Effects of Oral Citrulline on Protein Metabolism in Healthy Humans: a Prospective, Randomized, Double-blind , Cross-over Study" |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00756080 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Ronan THIBAULD, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Nantes |
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Name:
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Dominique Darmaun, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Nantes |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Subjects
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Intervention(s)
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Drug: placebo
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Drug: citrulline
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Primary Outcome(s)
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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
[Time Frame: No]
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Secondary Outcome(s)
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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)
[Time Frame: No]
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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
[Time Frame: No]
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Secondary ID(s)
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BRD 07/12-D
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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