Plant-Protein Dominant Tube Feed Study

Exploratory Randomised, Controlled Trial To Evaluate The Impact Of Four Nutritionally Complete, Plant-Protein Dominant, Enteral Tube Feeds On Long Term Outcomes In Community-Based Adults

This study aims to determine whether a reformulated plant-protein dominant protein blend in four existing enteral tube feeds is as effective as animal-protein dominant formulations in patients who are tube fed at home. This is an exploratory randomised, controlled, trial with a 3-day baseline period. Adult home tube feeding patients will be randomised to receive either a plant-protein dominant formulation or a control product (an animal-protein dominant formulation) for a 3-month intervention period followed by a 6-month and 12-month follow-up. The outcomes include gastrointestinal tolerance, compliance, acceptability, anthropometry, nutrient intake, and physical function

Study Overview

• Status: Recruiting
• Conditions: Enteral Feeds; Enteral Nutrition (Food for Special Medical Purposes)
• Intervention / Treatment: Dietary supplement: Plant-protein dominant enteral feed; Dietary supplement: Animal-protein dominant enteral feed

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Bell; Phone Number: +7717498628; Email: sophie.bell@nutricia.com
• Study Contact Backup: Name: Ellen Taylor; Email: ellen.taylor@nutricia.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 500ml (≥500kcal) per day 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plant-Protein Dominant Intervention; During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the plant-protein dominant feeds.	Dietary supplement: Plant-protein dominant enteral feed; Patients randomised to the Intervention Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 plant-protein dominant enteral feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).
Active Comparator: Animal-Protein Dominant Control; During the 3-day baseline period, each patient will receive their usual enteral tube feeding prescription as determined by their dietitian. Following the 3-day baseline period, all patients will enter the 90-day intervention period, where they will receive one (or a combination) of the animal-protein dominant feed (control) daily.	Dietary supplement: Animal-protein dominant enteral feed; Patients randomised to the Control Group will continue their existing tube feed for 3 days (baseline period) after which they will then receive one (or a combination) of the 4 animal-protein dominant control feeds (1kcal/ml or 1.5kcal/ml, with or without fibre) for 3 months. Patients who chose to remain on the study feed following the duration of the trial will be invited to participate in the full 12-month follow up (an additional 9 months), where data will be collected at 6- and 12-months. The feed prescription will be determined on an individual basis by the dietitian responsible for the patient's nutritional management but will be a minimum of 500ml feed per day (providing ≥500kcal).

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 (Day 93) and end of follow up (12 months)
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 (1 strongly disagree - 7 strongly agree)	Baseline (Day 1) to end of intervention (Day 93) 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 (93 days) and end of follow-up (12 months)
Nutritional 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 daily nutritional intake i.e., total energy intake (kcal/day) and macro- and micronutrients (g/day or mg/day).	Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Body weight	Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. Height and weight measures will be used to calculate body mass index (BMI) as kg/m^2.	Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Height	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) as kg/m^2.	Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Calf circumference	Calf circumference will be measured using standard measures to the nearest 0.1cm	Baseline to end of intervention (Day 93) and end of follow-up (12 months)
30-s Chair Stand Test	Number of times patients can stand up and sit down from a chair within 30 seconds.	Baseline to end of intervention (Day93) and end of follow-up (12 months)
Handgrip strength	A novel dynamometer will be used to assess muscle strength (kg) via a maximal grip strength test	Baseline to end of intervention (Day93) and end of follow-up (12 months)
Hand Grip Fatiguability	Muscle fatigability (in seconds) will be measured using a fatigue resistance test on a novel hand grip dynamometer	Baseline to end of intervention (Day93) and end of follow-up (12 months)
Capacity to Perceived Vitality (CPV) ratio	Vitality capacity, measured as Capacity to Perceived Vitality (CPV) ratio will be calculated using fatiguability, measured with a novel hand grip dynamometer combined, combined with the score from a validated questionnaire	Baseline to end of intervention (Day93) and end of follow-up (12 months)
Sarc-CalF tool	Sarcopenia screening tool consisting of a 5 question questionnaire combined with calf circumference measurement. A score ≥ 11 points is suggestive of sarcopenia.	Baseline to end of intervention (Day93) and end of follow-up (12 months)

Collaborators and Investigators

• Sponsor: Nutricia UK Ltd
• Collaborators: University College London Hospitals; Nottingham University Hospitals NHS Trust; University Hospitals Coventry and Warwickshire NHS Trust; University Hospitals of Derby and Burton NHS Foundation Trust; University Hospital Birmingham; Gateshead Health NHS Foundation Trust; Bradford Teaching Hospitals NHS Foundation Trust; Birmingham Community Healthcare NHS; South Warwickshire NHS Foundation Trust; NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PPD2025

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