Plant-Protein Dominant Tube Feed Study

Nutricia UK Ltd110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

110

Conditions

Enteral Nutrition (Food for Special Medical Purposes)Enteral Feeds

Interventions

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).

Animal-protein dominant enteral feedDIETARY_SUPPLEMENT

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).

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 500ml (≥500kcal) per day 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.

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 (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.