Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Enteral Intermittent; Dietary Supplement: Enteral Continuous; Dietary Supplement: Parenteral Continuous

• Registration Number: NCT00856219
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-05
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral Intermittent	Enteral Intermittent	Intermittent tube feedings for 72 hours
Enteral Continuous	Enteral Continuous	Continuous tube feeding for 72 hours.
Parenteral	Parenteral Continuous	Parenteral continuously for 72 hours

Primary Outcome Measures

Name	Time	Method
Route and type of feeding on Immune response	Day 1- Day 4

Trial Locations

Locations (1)

Rutgers-RWJMS; 🇺🇸 New Brunswick, New Jersey, United States