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NCT Number: NCT07422935

Plant-Protein Dominant Tube Feed Study

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

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Key information

Conditions

Enteral Nutrition (Food for Special Medical Purposes) Enteral Feeds

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutricia Ltd

Trowbridge, Wiltshire, BA14 0XQ, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plant-protein dominant enteral feed

Dietary 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 feed

Dietary 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).

Primary outcomes

  1. 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).

  2. 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)

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen Taylor

CONTACT

[email protected]

Sophie Bell

CONTACT

[email protected]

+7717498628

Sponsors and collaborators

Lead sponsor

Nutricia UK Ltd

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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