Status:

COMPLETED

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

Lead Sponsor:

Nantes University Hospital

Conditions:

Healthy Subjects

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

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 as...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT00756080

Start Date

September 1 2008

End Date

January 1 2009

Last Update

March 9 2010

Active Locations (1)

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Page 1 of 1 (1 locations)

1

CHU Nantes

Nantes, France, 44093