Clinical Trials Directory

Trials / Completed

CompletedNCT05411848

2kcal Tube Feed Study

Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Nutricia UK Ltd · Industry
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

The primary aim of this study is to investigate the effects of a plant-based, high energy, high protein tube feed with and without inclusion of fibre on gastrointestinal tolerance in adult patients who require nutritional support via enteral tube feeding over a 28-day period, followed by a 12-month follow-up. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and physical function. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period and a 1-year follow-up.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENT2kcal HP PlantBasedPatients 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.

Timeline

Start date
2022-05-17
Primary completion
2023-12-15
Completion
2023-12-15
First posted
2022-06-09
Last updated
2025-02-26

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05411848. Inclusion in this directory is not an endorsement.