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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950976
First Posted: August 3, 2009
Last Update Posted: April 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
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 Intervention
Nutritional Deficiency Other: citrulline Other: Lemonade

Study Type: Interventional
Study Design: 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

Further study details as provided by Nestlé:

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

Enrollment: 14
Study Start Date: March 2008
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citrulline Other: citrulline
TID for 5 days
Placebo Comparator: lemonade
Equal volume and flavor to citrulline.
Other: Lemonade
TID for 5 days

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00950976     History of Changes
Other Study ID Numbers: ACSC-CIT-04-06-US
First Submitted: July 10, 2009
First Posted: August 3, 2009
Last Update Posted: April 25, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders