Clinical trial NCT03459001: Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2018-03-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients ≥ 18 years of age 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 will be recruited.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tube Feed Product Compliance
timeFrame: Day 1 to Day 20
Secondary outcomes:
measure: Adverse Events
timeFrame: Day 0 to Day 20
measure: Body Mass Index
timeFrame: Day 0 to Day 20
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Residencia Plata y Castañar
city: Madrid
country: Spain
facility: Residencia Albertia Moratalaz
city: Madrid
country: Spain
facility: Residencia Valle de la Oliva
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe 3065
city: Valencia
country: Spain
facility: Hospital La Fe 3066
city: Valencia
country: Spain
facility: Hospital La Fe de Valencia 3033
city: Valencia
country: Spain
facility: Hospital La Fe de Valencia
Study officials:
affiliation: Abbott Nutrition
name: Maria Camprubi Robles, PhD
role: STUDY_CHAIR
References: