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OpenTrials
Completed

NCT Number: NCT02698540

A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment

The purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Germans Trias i Pujol, Badalona, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥2.
  • Subject is ≥18 years old.
  • Subject has a condition that would benefit from a high calorie, higher protein ONS for GI tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating).
  • Subject conforms to the requirements set forth on the study product label.
  • Subject is under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/day of the study ONS. Subject must have been naïve to ONS for GI tolerance impairment prior to being prescribed the study ONS.

Exclusion criteria

  • The study physician determines the subject is not fit to participate
  • Subject cannot provide informed consent to participate in the study.
  • Subject cannot safely consume the oral nutritional supplement.
  • Renal or liver failure (GFR< 60 ml/min or AST/ALTx3 normal) upper limit.
  • Type 1 or type 2 diabetes.

Treatment and study plan

Nutritional Supplement

Other

High calorie, high protein peptide based

Primary outcomes

  1. Study Product Compliance

    Time frame: Baseline to Week 12

    Subject reported diaries

Secondary outcomes

  1. Body Weight

    Time frame: Baseline to Week 12

  2. Nutrition Status

    Time frame: Baseline to Week 12

    Healthcare Professional completed screening

  3. Quality of Life

    Time frame: Baseline to Week 12

    Subject reported questionnaire

  4. Gastrointestinal Tolerance

    Time frame: Baseline to Week 12

    Subject reported scale

  5. Body Mass Index

    Time frame: Baseline to Week 12

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

A Prospective, Observational Study, of a High Calorie, Higher Protein Peptide Based Oral Nutrition Supplement (ONS) With Medium Chain Triglycerides (MCTs) in a Malnourished Population With GI Tolerance Impairment

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2016
Registry last updated
Aug 27, 2018

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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