About this trial
This study aims to assess the influence of specialized products based on ice cream on esophageal motility
Eligibility criteria
Qualifiers
willingness to participate based on signed written informed consent;
no qualitative changes in treatment within 6 months before enrollment (i.e., the introduction of a new antidiabetic therapy);
doses of anti-diabetic medications should be stable for 6 month in patients who receive metformin, gliptins, sulfonylureas, sodium/glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 agonists (GLP-1) or insulin.
no new medications during participation in the study
Disqualifiers
Pregnancy and breastfeeding;
Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM > or = 14 kPa by Fibroscan), or APRI > or= 1; or BARD score > or = 2.
Diarrhea of any type (watery stool more than 3 times a day).
Chronic heart failure (I-IV class by NYHA).
Trial design
Treatments tested in this trial
- specialized food based on ice cream, order 1
- specialized food based on ice cream, order 2
- specialized food based on ice cream, order 3
Treatment groups
Sponsors and collaborators
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Lead sponsor
Russian Science Foundation
Collaborator
Group of companies EFKO
Collaborator