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

This study has been completed.
Information provided by (Responsible Party):
Nestlé Identifier:
First received: July 10, 2009
Last updated: April 24, 2012
Last verified: April 2012

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:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00950976

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
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 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:
Nutrition Disorders processed this record on April 23, 2014