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

Primary Purpose

Nutritional Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
citrulline
Lemonade
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutritional Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • cancer
  • HIV positive

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Citrulline

lemonade

Arm Description

Equal volume and flavor to citrulline.

Outcomes

Primary Outcome Measures

Plasma amino acid levels

Secondary Outcome Measures

Full Information

First Posted
July 10, 2009
Last Updated
April 24, 2012
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT00950976
Brief Title
Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients
Official Title
Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citrulline
Arm Type
Experimental
Arm Title
lemonade
Arm Type
Placebo Comparator
Arm Description
Equal volume and flavor to citrulline.
Intervention Type
Other
Intervention Name(s)
citrulline
Intervention Description
TID for 5 days
Intervention Type
Other
Intervention Name(s)
Lemonade
Intervention Description
TID for 5 days
Primary Outcome Measure Information:
Title
Plasma amino acid levels
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults, male & female, non-pregnant BMI 18.5-29.9 Exclusion Criteria: cancer HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan B. Ochoa, MD Prof.
Organizational Affiliation
Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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