Plant-Protein Dominant Tube Feed Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorNutricia UK Ltd
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Plant-protein dominant enteral feed
Dietary supplementPatients 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 supplementPatients 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).
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Plant-Protein Dominant InterventionExperimental treatment 1 intervention
Group B: Animal-Protein Dominant ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Nutricia UK Ltd
Lead sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborator
Gateshead Health NHS Foundation Trust
Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust
Collaborator
Bradford Teaching Hospitals NHS Foundation Trust
Collaborator
University College London Hospitals
Collaborator
South Warwickshire NHS Foundation Trust
Collaborator
Birmingham Community Healthcare NHS
Collaborator
University Hospital Birmingham
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator
Ashford and St. Peter's Hospitals NHS Trust
Collaborator
East of England Community Health and Care NHS Trust
Collaborator
Source ClinicalTrials.gov