Clinical Evidence

Peer-reviewed research on the Alsteni System published in leading scientific journals.

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Nutrition & Diabetes (Springer Nature)

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

Beale, E.L., Vlaskovsky, P., Garlick, D. et al.

2020 · PMID: 32555148

Study Design
Type
Feasibility pilot randomized trial
Population
Ambulatory adults with obesity and type 2 diabetes
Intervention
Single mixed-meal bolus delivered to upper intestine via nasoenteral tube
Key Measures
Body weight, GLP-1, PYY, insulin, appetite
Key Findings
334
Tube-days completed with zero serious adverse events, establishing an initial safety signal for the intraoral anchoring approach.
Ad lib
Participants ate ad libitum throughout the study period — no caloric restriction was imposed.
GLP-1
The study measured circulating gut hormone and insulin levels following enteral nutrient delivery. Hormone and appetite data are reported in the published manuscript.

This study evaluated an early prototype and represents feasibility-stage data. Results should not be interpreted as evidence of the commercial device’s safety or effectiveness. The Alsteni System is an investigational device not yet cleared by FDA.