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CompletedNCT03459001Updated Apr 19, 2019

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

An observational study in Malnutrition, sponsored by Abbott Nutrition. Completed at 9 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-19.

Sponsored by Abbott Nutrition · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Malnutrition

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherTube Feeding Product

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

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What researchers measure

Primary outcomes

  1. Tube Feed Product Compliance

    Average Daily Intake and Proportion of Days Compliant

    Time frame: Day 1 to Day 20

Secondary outcomes

  1. Adverse Events

    Non serious AE and SAE collection

    Time frame: Day 0 to Day 20

  2. Body Mass Index

    Weight, Height

    Time frame: Day 0 to Day 20

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Study locations

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

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03459001
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Jun 8, 2018
Primary completion
Feb 7, 2019
Completion
Feb 7, 2019
Last update
Apr 19, 2019

Study contacts

Maria Camprubi Robles, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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