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
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in gastrointestinal tolerance
Timeframe: Change from baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)
Acceptability
Timeframe: Baseline (Day 1) to end of intervention (Day 93) and end of follow up (12 months)
Compliance
Timeframe: Baseline to end of intervention (93 days) and end of follow-up (12 months)
Nutritional intake
Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Body weight
Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Height
Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
Calf circumference
Timeframe: Baseline to end of intervention (Day 93) and end of follow-up (12 months)
30-s Chair Stand Test
Timeframe: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Handgrip strength
Timeframe: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Hand Grip Fatiguability
Timeframe: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Capacity to Perceived Vitality (CPV) ratio
Timeframe: Baseline to end of intervention (Day93) and end of follow-up (12 months)
Sarc-CalF tool
Timeframe: Baseline to end of intervention (Day93) and end of follow-up (12 months)