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Completed

NCT Number: NCT01357200

Feeding Trial 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.

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Key information

Conditions

Critical Illness Body Weight Disease Attributes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kentucky, Lexington, Kentucky, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Formula

Other

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

Primary outcomes

  1. time to feeding goal achievement

    Time frame: up to 5 days

    on all participants

Secondary outcomes

  1. gastrointestinal measures assessment

    Time frame: daily for up to 11 days

    on all participants

  2. percent of nutrition goal met

    Time frame: up to 5 days

    on all participants

  3. serum biochemical markers assessment

    Time frame: daily for up to 11 days

    on all participants

  4. assessment of frequency and nature of adverse events

    Time frame: daily for up to 11 days

    on all participants

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Enteral Formula Tolerance in the Obese Critical Care Population

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 20, 2011
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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