Feeding Trial in the Obese Critical Care Population

January 29, 2014 updated by: Société des Produits Nestlé (SPN)

Enteral Formula Tolerance in the Obese Critical Care Population

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

critically ill obese adults

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to feeding goal achievement
Time Frame: up to 5 days
on all participants
up to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastrointestinal measures assessment
Time Frame: daily for up to 11 days
on all participants
daily for up to 11 days
percent of nutrition goal met
Time Frame: up to 5 days
on all participants
up to 5 days
serum biochemical markers assessment
Time Frame: daily for up to 11 days
on all participants
daily for up to 11 days
assessment of frequency and nature of adverse events
Time Frame: daily for up to 11 days
on all participants
daily for up to 11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 15, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.02.US.CLI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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