NCT03459001CompletedNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 17
- Locations
- 9
- Primary Endpoint
- Tube Feed Product Compliance
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Malnourished or at risk for malnutrition based on the Malnutrition Universal Tool (MUST) score ≥
- •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.
Outcomes
Primary Outcomes
Tube Feed Product Compliance
Time Frame: Day 1 to Day 20
Average Daily Intake and Proportion of Days Compliant
Secondary Outcomes
- Adverse Events(Day 0 to Day 20)
- Body Mass Index(Day 0 to Day 20)
Investigators
Study Sites (9)
Loading locations...
Similar Trials
Completed
Not Applicable
A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance ImpairmentMalnutritionNCT02698540Abbott Nutrition95
Completed
Not Applicable
Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS)Amyotrophic Lateral SclerosisDietary HabitsDisorder of Fatty Acid MetabolismNCT02572479University of Jena50
Terminated
Phase 4
Effects of a Supplement Enriched in Hydroxymethylbutyrate and Vitamin D on Muscle Strength in Hip FractureHip FracturesNCT01850251Hospital Clinic of Barcelona2
Completed
Not Applicable
The Impact of a High-protein Diet on Energy Metabolism in Healthy MenDietary ModificationNCT03565510University of Alberta27
Unknown
Not Applicable
An Oral Nutritional Supplement Study in Older Malnourished Spanish PopulationMalnutritionNCT02404987Abbott Nutrition224