2kcal Tube Feed Study

Nutricia UK Ltd42 enrolled

Overview

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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Enteral Nutrition Cancer

Interventions

2kcal HP PlantBasedDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nutricia Ltd.

Trowbridge, Wiltshire, United Kingdom

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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