Clinical trial NCT05411848: 2kcal Tube Feed Study
Official title: Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Cancer
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 42
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female
* ≥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:

* Receiving parenteral nutrition
* 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.

Primary outcomes:
measure: Change in gastrointestinal tolerance
timeFrame: Change from baseline (Day 1) to end of intervention (7-28 days)
measure: Change in gastrointestinal tolerance
timeFrame: Change from baseline (Day 1) to end of follow-up (12 months)
Secondary outcomes:
measure: Acceptability
timeFrame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
measure: Compliance
timeFrame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
measure: Dietary intake
timeFrame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
measure: Anthropometry
timeFrame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
measure: Dietetic goal
timeFrame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
measure: Safety (Adverse events)
timeFrame: Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
measure: Calf circumference
timeFrame: 6-months to 12-months follow-up
measure: Handgrip strength
timeFrame: 6-months to 12-months follow-up
measure: 30-s Chair Stand Test
timeFrame: 6-months to 12-months follow-up
Other outcomes:
Locations:
city: Trowbridge
country: United Kingdom
facility: Nutricia Ltd.
state: Wiltshire
Study officials:
References: