Enteral Nutrition (Food for Special Medical Purposes)NCT07422935
Plant-Protein Dominant Tube Feed Study
A study testing Plant-protein dominant enteral feed and Animal-protein dominant enteral feed in people with Enteral Nutrition (Food for Special Medical Purposes) and Enteral Feeds, run by Nutricia UK Ltd at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Enteral Nutrition (Food for Special Medical Purposes), Enteral Feeds
- What is being tested?
- Plant-protein dominant enteral feed and Animal-protein dominant enteral feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marta Delsoglio contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nutricia Ltd
Trowbridge, Wiltshire, BA14 0XQ
About this study
Official title: 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
- Being tested
- Plant-protein dominant enteral feed, Animal-protein dominant enteral feed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-protein dominant enteral feedDietary supplement
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).
Animal-protein dominant enteral feedDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Plant-Protein Dominant Intervention | Experimental | 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. Receives: Dietary Supplement: Plant-protein dominant enteral feed |
| Animal-Protein Dominant Control | Active comparator | 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. Receives: Dietary Supplement: Animal-protein dominant enteral feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral Nutrition (Food for Special Medical Purposes)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory, randomised, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust, Gateshead Health NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, University College London Hospitals, South Warwickshire NHS Foundation Trust, Birmingham Community Healthcare NHS, University Hospital Birmingham, Nottingham University Hospitals NHS Trust, Ashford and St. Peter's Hospitals NHS Trust, East of England Community Health and Care NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422935
- Sponsor's protocol ID
- PPD2025
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07422935
- Acronym / sponsor ID
- PPD2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust, Gateshead Health NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, University College London Hospitals, South Warwickshire NHS Foundation Trust, Birmingham Community Healthcare NHS, University Hospital Birmingham, Nottingham University Hospitals NHS Trust, Ashford and St. Peter's Hospitals NHS Trust, East of England Community Health and Care NHS Trust
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Exploratory, randomised, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Plant-Protein Dominant Intervention | Experimental | Dietary Supplement: Plant-protein dominant enteral feedDuring 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. |
| Animal-Protein Dominant Control | Active comparator | Dietary Supplement: Animal-protein dominant enteral feedDuring 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-protein dominant enteral feedPatients 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). | Dietary supplement | Plant-Protein Dominant Intervention |
| Animal-protein dominant enteral feedPatients 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). | Dietary supplement | Animal-Protein Dominant Control |
Primary outcome
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).
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)
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.
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).
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.
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.
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
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.
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Delsoglio contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-protein dominant enteral feed and Animal-protein dominant enteral feed in people with Enteral Nutrition (Food for Special Medical Purposes) and Enteral Feeds, run by Nutricia UK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Bell (+7717498628, sophie.bell@nutricia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal tolerance (time frame: Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.