Gastrointestinal tolerance and compliance during a 2-week intervention of reformulated tube feeds with a plant-dominant protein blend in community-based adult patients on long-term nutritional support

BACKGROUND AND AIMS: Gastrointestinal (GI) tolerance is essential for effective tube feeding (TF) in patients with, or at risk of, disease-related malnutrition. This study evaluated GI tolerance, energy intake, compliance, body weight, and safety of four reformulated TFs with a higher proportion of plant-based proteins and improved vitamin composition versus commercially available TFs. METHODS: In this single-arm, open-label, multicountry study, 100 community-based adults on long-term TF continued their usual TF for one week (baseline week [BW]), followed by a 2-week intervention with one of four reformulated TFs (1.0 or 1.5 kcal/mL; with/without fiber) matched for energy density and fiber content. Outcomes included GI tolerance, energy intake, compliance, body weight, and safety. Results from the second intervention week (IW2) were compared with BW. RESULTS: 98% of subjects reported no or mild symptoms. The incidence of diarrhoea (BW: 2.0%, IW2: 1.0%) and constipation (BW: 0.0%, IW2: 1.0%) was very low. Compliance was ≥95% in 98% of subjects in BW and IW2. Energy intake (BW: 1396 ± 357 vs. IW2: 1400 ± 355 kcal/day, p = 0.954) and body weight (BW: 65.9 ± 12.0 vs. IW2: 66.1 ± 11.6 kg, p = 0.812) remained stable. No serious adverse events (AE) were reported. AEs were reported in 7 subjects (7%) during the intervention period, which were either unlikely related to the study product or as expected. CONCLUSIONS: Community-based adults on long-term TF, who used a reformulated TF with a plant-dominant protein blend for two weeks, tolerated the TF very well, maintained their body weight, and had excellent TF compliance. No safety concerns associated with these TFs were identified. These findings support their use in clinical practice. REGISTRATION NUMBER OF CLINICAL TRIAL: NCT05902806.