Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

This study is currently recruiting participants.

Verified by University of Medicine and Dentistry New Jersey, March 2009

First Received: March 4, 2009 No Changes Posted

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00856219

Purpose

Literature suggests that route of feeding and/or certain nutrients may cause alterations in the body's immune cells. Immune cells help protect the body and fight infection/disease. Tube feeding (TF) is a method of delivering nutrition directly to the stomach/intestines via a small tube. The immune system may respond differently when receiving continuous TF as compared to receiving intermittent TF. Heart rate variability (HRV, the intervals between heartbeats) is a measurement of the nervous system's response to a stress/illness. The differences in immune cells and/or HRV may influence how the body reacts to complications such as infection.

Condition	Intervention	Phase
Healthy	Other: Route of Feeding	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title:	Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Route and type of feeding on Immune response [ Time Frame: Day 1- Day 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Continuous vs Intermittent Feeding

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

General good health as demonstrated by medical history, physical& laboratory tests
Age between 18 and 40 years
Written informed consent prior to the performance of any study related procedures

Exclusion Criteria:

History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
Any medication taken in past 48 hrs (except birth control)
Recent history of alcohol or drug abuse
Unable to provide written informed consent
Exposure to any experimental agent or procedure within 30 days of study
Pregnant or breast-feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856219

Contacts

Contact: Marie Macor, RN	732-235-8143	macorma@umdnj.edu
Contact: Susette Coyle, RN	732-235-8143	coylesu@umdnj.edu

Locations

United States, New Jersey
UMDNJ-RWJMS	Recruiting
New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Investigators

Principal Investigator:

Stephen F Lowry, MD

UMDNJ-RWJMS

More Information

No publications provided

Responsible Party:	UMDNJ-RWJMS ( Stephen F. Lowry, MD )
Study ID Numbers:	0220044983, NIH/DHHS GM34695
Study First Received:	March 4, 2009
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00856219 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

Immune System

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 10, 2009