Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
- Conditions
- Malnutrition
- Registration Number
- NCT03459001
- Lead Sponsor
- Abbott Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tube Feed Product Compliance Day 1 to Day 20 Average Daily Intake and Proportion of Days Compliant
- Secondary Outcome Measures
Name Time Method Adverse Events Day 0 to Day 20 Non serious AE and SAE collection
Body Mass Index Day 0 to Day 20 Weight, Height
Trial Locations
- Locations (9)
Residencia Plata y Castañar
🇪🇸Madrid, Spain
Residencia Albertia Moratalaz
🇪🇸Madrid, Spain
Residencia Valle de la Oliva
🇪🇸Madrid, Spain
Hospital Clinico de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital La Fe 3065
🇪🇸Valencia, Spain
Hospital La Fe 3066
🇪🇸Valencia, Spain
Hospital La Fe de Valencia 3033
🇪🇸Valencia, Spain
Hospital La Fe de Valencia
🇪🇸Valencia, Spain
Residencia Plata y Castañar🇪🇸Madrid, Spain