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

Nutritional Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950976
• Other study ID #: ACSC-CIT-04-06-US
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: April 24, 2012
• Start date: March 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2012
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults, male & female, non-pregnant

• BMI 18.5-29.9

Exclusion Criteria:

• cancer

• HIV positive

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiency

Intervention

Other:
• citrulline
TID for 5 days
• Lemonade
TID for 5 days

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma amino acid levels		8 hours	No