Plant-Protein Dominant Tube Feed Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Plant-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).

Animal-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).

Study 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

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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