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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
Nutricia Ltd.
Trowbridge, Wiltshire, United Kingdom
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 (7-28 days)
Change in gastrointestinal tolerance
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity
Time frame: Change from baseline (Day 1) to 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
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Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 6-months to 12-months follow-up
Handgrip strength
Dominant handgrip strength (kg) will be assessed using a handgrip dynamometer
Time frame: 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.
Time frame: 6-months to 12-months follow-up