Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2022-05-17
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.
2kcal HP PlantBased
Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.
Interventions
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2kcal HP PlantBased
Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.
Eligibility Criteria
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Inclusion Criteria
* ≥16 years of age
* Using or requiring an enteral tube feed in the community as part of nutritional management plan
* Expected to receive at least 1000kcal/day (one bottle) from one of the study products
Exclusion Criteria
* Patients with major hepatic dysfunction (i.e., decompensated liver disease)
* Patients with major renal dysfunction (i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD))
* Patients receiving inpatient care
* Known pregnancy or lactation
* Participation in other clinical intervention studies within 1 month of this study
* Allergy to any study product ingredients
* Investigator concern regarding ability or willingness of patient to comply with the study requirements.
16 Years
ALL
No
Sponsors
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Nutricia UK Ltd
INDUSTRY
Responsible Party
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Locations
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Nutricia Ltd.
Trowbridge, Wiltshire, United Kingdom
Countries
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Other Identifiers
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2KCAL2022
Identifier Type: -
Identifier Source: org_study_id
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