The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFederal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

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

30 Participants
are divided into 3 treatment groups

Locations

1
Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.115446, Moscow Russia

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