Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00856219
First received: March 4, 2009
Last updated: April 24, 2013
Last verified: April 2013
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

Further study details as provided by Rutgers, The State University of New Jersey:

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

Enrollment: 12
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Route of Feeding
    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
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: NCT00856219

Locations
United States, New Jersey
Umdnj-Rwjms
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Siobhan Corbett, MD UMDNJ-RWJMS
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00856219     History of Changes
Other Study ID Numbers: 0220044983, NIH/DHHS GM34695
Study First Received: March 4, 2009
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Immune System

ClinicalTrials.gov processed this record on July 20, 2014