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Feeding Trial in the Obese Critical Care Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357200
First Posted: May 20, 2011
Last Update Posted: January 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.

Condition Intervention
Critical Illness Obesity 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 ]
    on all participants


Secondary Outcome Measures:
  • gastrointestinal measures assessment [ Time Frame: daily for up to 11 days ]
    on all participants

  • percent of nutrition goal met [ Time Frame: up to 5 days ]
    on all participants

  • serum biochemical markers assessment [ Time Frame: daily for up to 11 days ]
    on all participants

  • assessment of frequency and nature of adverse events [ Time Frame: daily for up to 11 days ]
    on all participants


Biospecimen Retention:   Samples Without DNA
serum

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
critically ill obese adults
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357200


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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01357200     History of Changes
Other Study ID Numbers: 10.02.US.CLI
First Submitted: May 15, 2011
First Posted: May 20, 2011
Last Update Posted: January 30, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes