An interventional study of Plant-protein dominant enteral feed and Animal-protein dominant enteral feed in Enteral Nutrition (Food for Special Medical Purposes) and Enteral Feeds, sponsored by Nutricia UK Ltd. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Nutricia UK Ltd (part of Danone) · Not applicable, Interventional, and Treatment
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
Nutricia UK Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Male or female
-≥16 years of age
Exclusion Criteria:
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
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 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).
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).
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).
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Plan to share: No
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Started Jan 2026 (actual). Primary completion is estimated for Jul 2028, 30 months after the start.
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