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

Abbott

Status: Completed

Conditions: Malnutrition

Treatments: Other: Tube Feeding Product

Study type: Observational

Funder types: Industry

Identifiers

NCT03459001

BL32

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

17 participants in 1 patient group

Tube Fed Malnourished Outpatients

Description:

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

Treatment:

Other: Tube Feeding Product