Feeding Trial in the Obese Critical Care Population

Obesity Clinical Trial

Official title:

Enteral Formula Tolerance in the Obese Critical Care Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357200
• Other study ID #: 10.02.US.CLI
• Status: Completed
• Phase: N/A
• First received: May 15, 2011
• Last updated: January 29, 2014
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.

Description:

Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Surgical or Medical intensive care unit (ICU) patient

• Body mass index (BMI) = 30

Exclusion Criteria:

• pregnant or lactating

• unable to access gastrointestinal (GI) tract for feeding via tube

• other contraindication to tube feeding

• admitted with burns

• severe head trauma

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Obesity

Intervention

Other:
• enteral formula
Complete feeding of study enteral formula, route and regime prescribed by the physician.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to feeding goal achievement	on all participants	up to 5 days	No
Secondary	gastrointestinal measures assessment	on all participants	daily for up to 11 days	No
Secondary	percent of nutrition goal met	on all participants	up to 5 days	No
Secondary	serum biochemical markers assessment	on all participants	daily for up to 11 days	No
Secondary	assessment of frequency and nature of adverse events	on all participants	daily for up to 11 days	No