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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459001
• Other study ID #: BL32
• Status: Completed
• Start date: June 8, 2018
• Est. completion date: February 7, 2019

Study information

• Verified date: April 2019
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 7, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Spain	Residencia Albertia Moratalaz	Madrid
Spain	Residencia Plata y Castañar	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	Valencia
Spain	Hospital La Fe de Valencia 3033	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tube Feed Product Compliance	Average Daily Intake and Proportion of Days Compliant	Day 1 to Day 20
Secondary	Adverse Events	Non serious AE and SAE collection	Day 0 to Day 20
Secondary	Body Mass Index	Weight, Height	Day 0 to Day 20