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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00950976
First received: July 10, 2009
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Plasma amino acid levels [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00950976     History of Changes
Other Study ID Numbers: ACSC-CIT-04-06-US
Study First Received: July 10, 2009
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 19, 2013