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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03459001 |
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Date of registration:
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02/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition
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Scientific title:
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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 |
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Date of first enrolment:
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June 8, 2018 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03459001 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Spain
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Contacts
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Name:
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Maria Camprubi Robles, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott Nutrition |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malnutrition
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Intervention(s)
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Other: Tube Feeding Product
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Primary Outcome(s)
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Tube Feed Product Compliance
[Time Frame: Day 1 to Day 20]
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Secondary Outcome(s)
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Adverse Events
[Time Frame: Day 0 to Day 20]
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Body Mass Index
[Time Frame: Day 0 to Day 20]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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