This study aims to assess the influence of specialized products based on ice cream on esophageal motility
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
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).
Crossover
specialized food based on ice cream, order 1
Other interventionOrder of intervention: 1. ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose; 2: ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin; 3: standard ice cream (12% fat)
specialized food based on ice cream, order 2
Other intervention1. ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin; 2. ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose; 3. standard ice cream (12% fat)
specialized food based on ice cream, order 3
Other intervention1. standard ice cream (12% fat) 2. ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose 3. ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin
Mean lower esophageal sphincter resting pressure
Based on the high-resolution esophageal manometry measurement
Distal contractile integral
mean lower esophageal sphincter integral relaxation pressure
IRP 4
Mean contractile front velocity
CFV
mean upper esophageal sphincter resting pressure
mean UES resting pressure
Mean upper esophageal sphincter integrated relaxation pressure
Mean UES IRP 2 sec
product organoleptic assessment
organoleptic assessment on taste, scent, colour and texture with the use of a special form based on visual-analogue scale (range: 1 - 5, where 1 is worse assessment, and 5 - favourable assessment)
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Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Lead sponsor
Russian Science Foundation
Collaborator
Group of companies EFKO
Collaborator
