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

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

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 Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Other: Tube Feeding Product

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28021
    • Residencia Plata y Castañar
  • Madrid, Spain, 28030
    • Residencia Albertia Moratalaz
  • Madrid, Spain, 28220
    • Residencia Valle de la Oliva
  • Valencia, Spain, 46010
    • Hospital Clinico de Valencia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital La Fe de Valencia
  • Valencia, Spain, 46026
    • Hospital La Fe 3065
  • Valencia, Spain, 46026
    • Hospital La Fe 3066
  • Valencia, Spain, 46026
    • Hospital La Fe de Valencia 3033

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tube Fed Malnourished Outpatients; 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	Other: Tube Feeding Product; a high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tube Feed Product Compliance	Average Daily Intake and Proportion of Days Compliant	Day 1 to Day 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Non serious AE and SAE collection	Day 0 to Day 20
Body Mass Index	Weight, Height	Day 0 to Day 20

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Maria Camprubi Robles, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2018
• Primary Completion (Actual): February 7, 2019
• Study Completion (Actual): February 7, 2019

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BL32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No