NCT03459001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2019

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

March 2, 2018

Last Update Submit

April 18, 2019

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Tube Feed Product Compliance

    Average Daily Intake and Proportion of Days Compliant

    Day 1 to Day 20

Secondary Outcomes (2)

  • Adverse Events

    Day 0 to Day 20

  • Body Mass Index

    Day 0 to Day 20

Study Arms (1)

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

Interventions

Tube Feeding ProductOTHER

a high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care

Tube Fed Malnourished Outpatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Residencia Plata y Castañar

Madrid, 28021, Spain

Location

Residencia Albertia Moratalaz

Madrid, 28030, Spain

Location

Residencia Valle de la Oliva

Madrid, 28220, Spain

Location

Hospital Clinico de Valencia

Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital La Fe 3065

Valencia, 46026, Spain

Location

Hospital La Fe 3066

Valencia, 46026, Spain

Location

Hospital La Fe de Valencia 3033

Valencia, 46026, Spain

Location

Hospital La Fe de Valencia

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Maria Camprubi Robles, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 8, 2018

Study Start

June 8, 2018

Primary Completion

February 7, 2019

Study Completion

February 7, 2019

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

ES(9)