Malnutrition
Conditions
Brief summary
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.
Interventions
OTHERTube Feeding Product
a high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care
Sponsors
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tube Feed Product Compliance | Day 1 to Day 20 | Average Daily Intake and Proportion of Days Compliant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Day 0 to Day 20 | Non serious AE and SAE collection |
| Body Mass Index | Day 0 to Day 20 | Weight, Height |
Countries
Spain
Outcome results
None listed