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

Completed

• 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

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-06-08
• Primary Completion: 2019-02-07
• Study Completion: 2019-02-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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