2kcal Tube Feed Study

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the effects of a plant-based, high energy, high protein tube feed with and without inclusion of fibre on gastrointestinal tolerance in adult patients who require nutritional support via enteral tube feeding over a 28-day period, followed by a 12-month follow-up. Secondary aims are to determine the effects on compliance, acceptability, anthropometry, nutrient intake, and physical function. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period and a 1-year follow-up.

Official Title
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Evaluation of a Nutritionally Complete, Plant-based, High Energy, High Protein, Enteral Tube Feed in Adults

Conditions
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Cancer, Enteral Nutrition

Intervention / Treatment
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* Dietary Supplement: 2kcal HP PlantBased


Participation Criteria
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Eligibility Criteria
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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 1000kcal/day (one bottle) 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period. | Dietary Supplement: 2kcal HP PlantBased<br>* Patients will receive a minimum of 1 bottle per day of either (or both of) 2kcal HP PlantBased and/or 2kcal HP PlantBased MultiFibre Tube Feeds for a minimum of 7 days and a maximum of 28 days. During the 12-month follow-up, patients will have access to the same trial prescription as per the 28-day intervention period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from baseline (Day 1) to end of intervention (7-28 days) | 
| Change in gastrointestinal tolerance | A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity | Change from baseline (Day 1) to end of follow-up (12 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to end of intervention (7-28 days) 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. | Baseline to end of intervention (7-28 days) and end of follow-up (12 months) | 
| Dietary 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 of nutritional intake (i.e., total energy and macro- and micronutrients). | Baseline to end of intervention (7-28 days) and end of follow-up (12 months) | 
| Anthropometry | Body weight (kg) will be measured using standard methods to the nearest 0.1kg using a weighing scale without heavy clothing. 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). | Baseline to end of intervention (7-28 days) and end of follow-up (12 months) | 
| Dietetic goal | A dietetic goal (e.g., weight increase/maintenance, improved/maintained GI tolerance, improved/maintained compliance) will be set by the investigating dietitian at baseline (Day 1) for each patient. At the end of the intervention period, the investigating dietitian will assess and note if the dietetic goal was met. | Baseline to end of intervention (7-28 days) and end of follow-up (12 months) | 
| Safety (Adverse events) | Adverse events will be recorded throughout the study | Baseline to end of intervention (7-28 days) and end of follow-up (12 months) | 
| Calf circumference | Calf circumference (of the dominant leg) will be measured using standard measures to the nearest 0.1cm using a measuring tape | 6-months to 12-months follow-up | 
| Handgrip strength | Dominant handgrip strength (kg) will be assessed using a handgrip dynamometer | 6-months to 12-months follow-up | 
| 30-s Chair Stand Test | Number of times patients can stand up and sit down from a chair as many times as possible within 30 seconds. | 6-months to 12-months follow-up |