NCT02698540
Completed
Not Applicable
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
ConditionsMalnutrition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- Abbott Nutrition
- Enrollment
- 95
- Locations
- 23
- Primary Endpoint
- Study Product Compliance
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥
- •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.
Outcomes
Primary Outcomes
Study Product Compliance
Time Frame: Baseline to Week 12
Subject reported diaries
Secondary Outcomes
- Nutrition Status(Baseline to Week 12)
- Quality of Life(Baseline to Week 12)
- Body Weight(Baseline to Week 12)
- Gastrointestinal Tolerance(Baseline to Week 12)
- Body Mass Index(Baseline to Week 12)
Study Sites (23)
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