Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

Phase 1

Completed

• Conditions: Healthy

• 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

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