A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment
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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.
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 :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study population will include men and women who are free living (outpatient) or residing in a nursing home.
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.
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.