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

April 24, 2012 updated by: Nestlé

Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • cancer
  • HIV positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma amino acid levels
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Juan B. Ochoa, MD Prof., Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACSC-CIT-04-06-US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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