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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014