Enteral Feeds, Enteral Nutrition (Food for Special Medical Purposes)
Conditions
Brief summary
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
Interventions
DIETARY_SUPPLEMENTPlant-protein dominant enteral feed
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).
DIETARY_SUPPLEMENTAnimal-protein dominant enteral feed
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).
Sponsors
Nutricia UK Ltd
University Hospitals Coventry and Warwickshire NHS Trust
Gateshead Health NHS Foundation Trust
University Hospitals of Derby and Burton NHS Foundation Trust
Bradford Teaching Hospitals NHS Foundation Trust
University College London Hospitals
South Warwickshire NHS Foundation Trust
Birmingham Community Healthcare NHS
University Hospital Birmingham
Nottingham University Hospitals NHS Trust
Ashford and St. Peter's Hospitals NHS Trust
East of England Community Health and Care NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Exploratory, randomised, controlled trial
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gastrointestinal tolerance | Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months) | 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). |
| Acceptability | Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months) | 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) |
| Compliance | Baseline to end of intervention (93 days) and end of follow-up (12 months) | 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. |
| Nutritional intake | Baseline to end of intervention (Day 93) and end of follow-up (12 months) | 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). |
| Body weight | Baseline to end of intervention (Day 93) and end of follow-up (12 months) | 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. |
| Height | Baseline to end of intervention (Day 93) and end of follow-up (12 months) | 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. |
| Calf circumference | Baseline to end of intervention (Day 93) and end of follow-up (12 months) | Calf circumference will be measured using standard measures to the nearest 0.1cm |
| 30-s Chair Stand Test | Baseline to end of intervention (Day93) and end of follow-up (12 months) | Number of times patients can stand up and sit down from a chair within 30 seconds. |
| Handgrip strength | Baseline to end of intervention (Day93) and end of follow-up (12 months) | A novel dynamometer will be used to assess muscle strength (kg) via a maximal grip strength test |
| Hand Grip Fatiguability | Baseline to end of intervention (Day93) and end of follow-up (12 months) | Muscle fatigability (in seconds) will be measured using a fatigue resistance test on a novel hand grip dynamometer |
| Capacity to Perceived Vitality (CPV) ratio | Baseline to end of intervention (Day93) and end of follow-up (12 months) | Vitality capacity, measured as Capacity to Perceived Vitality (CPV) ratio will be calculated using fatiguability, measured with a novel hand grip dynamometer combined, combined with the score from a validated questionnaire |
| Sarc-CalF tool | Baseline to end of intervention (Day93) and end of follow-up (12 months) | Sarcopenia screening tool consisting of a 5 question questionnaire combined with calf circumference measurement. A score ≥ 11 points is suggestive of sarcopenia. |
Countries
United Kingdom
Contacts
CONTACTSophie Bell
CONTACTMarta Delsoglio
Outcome results
None listed