Plant-Protein Dominant Tube Feed Study

February 13, 2026 updated by: Nutricia UK Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in gastrointestinal tolerance
Time Frame: Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)
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
Time Frame: Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)
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
Time Frame: Baseline to end of intervention (93 days) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)
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
Time Frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nutricia UK Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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