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Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients

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ClinicalTrials.gov Identifier: NCT00950976
Recruitment Status : Completed
First Posted : August 3, 2009
Last Update Posted : April 25, 2012
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.

Condition or disease Intervention/treatment Phase
Nutritional Deficiency Other: citrulline Other: Lemonade Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias
Study Start Date : March 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: Citrulline Other: citrulline
TID for 5 days
Placebo Comparator: lemonade
Equal volume and flavor to citrulline.
Other: Lemonade
TID for 5 days



Primary Outcome Measures :
  1. Plasma amino acid levels [ Time Frame: 8 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults, male & female, non-pregnant
  • BMI 18.5-29.9

Exclusion Criteria:

  • cancer
  • HIV positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950976


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Juan B. Ochoa, MD Prof. Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00950976     History of Changes
Other Study ID Numbers: ACSC-CIT-04-06-US
First Posted: August 3, 2009    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders