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

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.
 
ClinicalTrials.gov Identifier: NCT02698540
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
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.

Condition or disease Intervention/treatment
Malnutrition Other: Nutritional Supplement

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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : November 28, 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Nutritional Supplement
    High calorie, high protein peptide based


Primary Outcome Measures :
  1. Study Product Compliance [ Time Frame: Baseline to Week 12 ]
    Subject reported diaries


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include men and women who are free living (outpatient) or residing in a nursing home.
Criteria

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.

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): NCT02698540


Locations
Show Show 23 study locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Rebecca Sanz Barriuso, RD, PharmD Abbott Nutrition
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02698540    
Other Study ID Numbers: DA13
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders