Study Comparing Plant-Protein and Animal-Protein Tube Feeds in Adults Using Home Enteral Nutrition

What this Trial Is About

Researchers are evaluating whether a reformulated plant-protein dominant blend in enteral tube feeds works as well as animal-protein dominant feeds in adults who receive tube feeding at home. This exploratory randomized controlled trial includes a 3-day baseline period and aims to study gastrointestinal tolerance, compliance, acceptability, body measurements, nutrient intake, and physical function over time. Participants will first continue their usual tube feeding for 3 days during the baseline. Then, for 3 months, they will receive either one or a combination of four plant-protein dominant enteral feeds or animal-protein dominant feeds control. After this intervention period, those who wish to continue will be followed for an additional 9 months, with data collected at 6 and 12 months to assess long-term outcomes. During the study, participants will be monitored for changes in gastrointestinal tolerance, acceptability, and compliance, along with measurements of body weight, height, calf circumference, and physical function tests such as the 30-second Chair Stand Test and handgrip strength. Nutritional intake and vitality measures will also be tracked from baseline through the intervention and follow-up periods. The total study participation may last up to 12 months.

Plant-Protein Dominant Tube Feed Study