Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial

Background/objectives: To ascertain the effect on body weight of 14 days of bolus enteral feeding with mixed meal (MM) and electrolyte solution (ES) in ambulatory adults with type 2 diabetes and obesity, and also the safety and feasibility of using a modified, intraorally anchored enteral feeding tube for this purpose. Subjects/methods: We conducted a randomized, crossover pilot trial with 16 participants. A 140 cm, 8-French feeding tube was placed in the jejunum under electromagnetic guidance and anchored intraorally. Participants were randomized to self-administer 120 mL 523 kJ (125 kcal) MM, or 50 kJ (12 kcal) ES four times/day for 14 days. After ≥14 days without the tube, participants crossed over to the other treatment. The primary outcome compared weight change between treatments. Thereafter, participants could elect to undergo additional MM cycles. Participants were encouraged to continue with all usual activities including eating ad lib throughout the study. Results: Ten participants withdrew prior to completing two randomized 14-day cycles (4 social, 3 intolerant of anchor, and 3 intolerant of tube). Six participants were assessed for the primary outcome and showed no significant difference in weight loss between MM and ES (p = 0.082). For the secondary outcome of within-group weight loss, average weight loss from baseline was significant for MM but not for ES: -2.40 kg (95% CI: -3.78, -1.02; p=0.008) vs. -0.64 kg (95% CI: -2.01, 0.74; p = 0.27). A total of 23 2-week cycles were completed (12 paired, 2 unpaired, and 9 additional), with no significant adverse events for 334 days of tube use. Conclusions: Repeated bolus nutrient administration via enteral feeding tube is associated with weight loss in adults with obesity and type 2 diabetes, with no significant difference seen between MM and ES feeds. The prototype device was safe, but requires development for further investigation into the effect of bolus jejunal feeding on weight and to improve acceptability.