Feeding Trial in the Obese Critical Care Population

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: May 15, 2011
Last updated: January 29, 2014
Last verified: January 2014
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.

Condition Intervention
Critical Illness
Other: enteral formula

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Enteral Formula Tolerance in the Obese Critical Care Population

Resource links provided by NLM:

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • time to feeding goal achievement [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    on all participants

Secondary Outcome Measures:
  • gastrointestinal measures assessment [ Time Frame: daily for up to 11 days ] [ Designated as safety issue: No ]
    on all participants

  • percent of nutrition goal met [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    on all participants

  • serum biochemical markers assessment [ Time Frame: daily for up to 11 days ] [ Designated as safety issue: No ]
    on all participants

  • assessment of frequency and nature of adverse events [ Time Frame: daily for up to 11 days ] [ Designated as safety issue: No ]
    on all participants

Biospecimen Retention:   Samples Without DNA

Enrollment: 26
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
critically ill obese adults
Age ≥ 18 years, body mass index (BMI) ≥ 30, in intensive care unit (ICU) requiring tube feeding ≥ 3 days
Other: enteral formula
Complete feeding of study enteral formula, route and regime prescribed by the physician.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
critically ill obese adults

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01357200

United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01357200     History of Changes
Other Study ID Numbers: 10.02.US.CLI 
Study First Received: May 15, 2011
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 04, 2016