Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: Enteral Intermittent; Dietary Supplement: Enteral Continuous; Dietary Supplement: Parenteral Continuous

Study type: Interventional

Funder types: Other

Identifiers

NCT00856219

0220044983

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Enteral Continuous

Active Comparator group

Description:

Continuous tube feeding for 72 hours.

Treatment:

Dietary Supplement: Enteral Continuous

Enteral Intermittent

Active Comparator group

Description:

Intermittent tube feedings for 72 hours

Treatment:

Dietary Supplement: Enteral Intermittent

Parenteral

Active Comparator group

Description:

Parenteral continuously for 72 hours

Treatment:

Dietary Supplement: Parenteral Continuous