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Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects (Feeding)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00856219
First Posted: March 5, 2009
Last Update Posted: May 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  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 Dietary Supplement: Enteral Continuous Dietary Supplement: Enteral Intermittent Dietary Supplement: Parenteral Continuous Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

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)
Arms Assigned Interventions
Active Comparator: Enteral Continuous
Continuous tube feeding for 72 hours.
Dietary Supplement: Enteral Continuous
Continuous Tube Feeding for 72 hours
Active Comparator: Enteral Intermittent
Intermittent tube feedings for 72 hours
Dietary Supplement: Enteral Intermittent
Intermittent Tube Feedings
Active Comparator: Parenteral
Parenteral continuously for 72 hours
Dietary Supplement: Parenteral Continuous
Parenteral Continuously for 72 hours

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856219


Locations
United States, New Jersey
Rutgers-RWJMS
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Siobhan Corbett, MD Rutgers-RWJMS
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00856219     History of Changes
Other Study ID Numbers: 0220044983
First Submitted: March 4, 2009
First Posted: March 5, 2009
Last Update Posted: May 22, 2015
Last Verified: May 2015

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