Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rutgers-RWJMS

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Continuous

Dietary Supplement

Continuous Tube Feeding for 72 hours

Enteral Intermittent

Dietary Supplement

Intermittent Tube Feedings

Parenteral Continuous

Dietary Supplement

Parenteral Continuously for 72 hours

Primary outcomes

Route and type of feeding on Immune response

Time frame: Day 1- Day 4

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Acronym: Feeding

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Mar 5, 2009
Registry last updated: May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed