2kcal Tube Feed Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Enteral Nutrition
• Intervention / Treatment: Dietary supplement: 2kcal HP PlantBased

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wiltshire
    • Trowbridge, Wiltshire, United Kingdom, BA14 0XQ
      • Nutricia Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gastrointestinal tolerance	A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea).	Change from baseline (Day 1) to end of intervention (7-28 days)
Change in gastrointestinal tolerance	A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity	Change from baseline (Day 1) to end of follow-up (12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability (e.g., liking, ease of use, preference) will be assessed by a questionnaire. Questions will be rated on a 7-point Likert scale.	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Compliance	Compliance with the study product prescription (%) will be assessed daily by recording how much of the study product was prescribed compared to the amount administered.	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Dietary intake	A 24-h dietary recall will be conducted to record all food, drink and nutritional feeds taken in the 24 hours prior for analysis of of nutritional intake (i.e., total energy and macro- and micronutrients).	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Anthropometry	Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height will be measured at baseline only using standard measures to the nearest 0.1cm, without shoes or socks. . Height and weight measures will be used to calculate body mass index (BMI).	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Dietetic goal	A dietetic goal (e.g., weight increase/maintenance, improved/maintained GI tolerance, improved/maintained compliance) will be set by the investigating dietitian at baseline (Day 1) for each patient. At the end of the intervention period, the investigating dietitian will assess and note if the dietetic goal was met.	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Safety (Adverse events)	Adverse events will be recorded throughout the study	Baseline to end of intervention (7-28 days) and end of follow-up (12 months)
Calf circumference	Calf circumference (of the dominant leg) will be measured using standard measures to the nearest 0.1cm using a measuring tape	6-months to 12-months follow-up
Handgrip strength	Dominant handgrip strength (kg) will be assessed using a handgrip dynamometer	6-months to 12-months follow-up
30-s Chair Stand Test	Number of times patients can stand up and sit down from a chair as many times as possible within 30 seconds.	6-months to 12-months follow-up

Collaborators and Investigators

• Sponsor: Nutricia UK Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2KCAL2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No