Comparison of Enteral Versus Parenteral Feeding in Health... | NCT00856219

Studies
Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

NCT00856219

Sponsor

Rutgers, The State University of New Jersey

Status

Completed

Last Update Posted

May 22, 2015Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Enteral Continuous
Enteral Intermittent
Parenteral Continuous

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Mar 4, 2009

First Submission Date that Met QC Criteria

Mar 4, 2009

First Posted Date

Mar 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2015

Last Update Posted Date

May 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enteral Continuous	Active Comparator	Continuous tube feeding for 72 hours.	Dietary Supplement: Enteral Continuous
Enteral Intermittent	Active Comparator	Intermittent tube feedings for 72 hours	Dietary Supplement: Enteral Intermittent
Parenteral	Active Comparator	Parenteral continuously for 72 hours	Dietary Supplement: Parenteral Continuous

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enteral Continuous	Dietary Supplement	Continuous Tube Feeding for 72 hours	Enteral Continuous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Route and type of feeding on Immune response		Day 1- Day 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Siobhan Corbett, MD	Rutgers-RWJMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rutgers-RWJMS		New Brunswick	New Jersey	08901	United States