Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition

Study Overview
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Brief Summary
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This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care.

Official Title
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A Prospective, Observational Study to Evaluate the Use of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition

Conditions
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Malnutrition

Intervention / Treatment
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* Other: Tube Feeding Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malnourished or at risk for malnutrition based on the Malnutrition Universal Tool (MUST) score ≥ 2. Under the care of a health care professional for malnutrition or at risk of malnutrition and has been prescribed the study formula. Requires and agrees to be tube fed the enteral feeding product for at least 16 consecutive days as their sole-source of nutritional intake. Free living in the community or is residing in a nursing home. Conforms to the requirements set forth on the study product label. Exclusion Criteria: Currently taking or has taken antibiotics within 2 weeks prior to enrollment. Consuming food PO. Current active cancer and the study physician determines that the subject is not suitable for the study. History of diabetes mellitus as evidenced by taking anti-hyperglycemic medications or by self-reported dietary modification for control of diabetes mellitus. Renal or liver failure. Pregnant as demonstrated by self-report. Severe auto immune disease (per physician's discretion) and is on immuno-modulating therapy. History of allergy to any of the ingredients in the study product. Active Human Immunodeficiency Virus (HIV). Known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption and does not have a caregiver who can assist them with adherence to the study protocol. Condition that is contraindicated to tube feeding the study product. Taking part in a non-approved clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tube Fed Malnourished Outpatients<br>Outpatients that are malnourished or at risk of malnutrition and have been placed on a nutritional care plan, which includes a complete tube feeding formula as sole source nutrition | Other: Tube Feeding Product<br>* a high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tube Feed Product Compliance | Average Daily Intake and Proportion of Days Compliant | Day 1 to Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Non serious AE and SAE collection | Day 0 to Day 20 | 
| Body Mass Index | Weight, Height | Day 0 to Day 20 |