This study aims to assess the influence of specialized products based on ice cream on esophageal motility
During this study participants will be examined with the use of high-resolution esophageal motility. After standard procedure, according to Chicago IV protocol, subjects will be provided with 3 different types of food products: standard icecream (sundae), icecream with brazzein, maltitol and oligofructose; icecream with brazzein, erythritol, maltitol and inulin. Tolerability of products will be assessed based on specialized scales and formal questioning.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
30
Order 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)
1. 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)
1. 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
Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.
Moscow, Russia
RECRUITINGMean lower esophageal sphincter resting pressure
Based on the high-resolution esophageal manometry measurement
Time frame: baseline, during the intervention
Distal contractile integral
Time frame: baseline, during the intervention
mean lower esophageal sphincter integral relaxation pressure
IRP 4
Time frame: baseline, during the intervention
Mean contractile front velocity
CFV
Time frame: baseline, during the intervention
Distal latency
DL
Time frame: baseline, during the intervention
Mean intrabolus pressure
IBP
Time frame: baseline, during the intervention
mean upper esophageal sphincter resting pressure
mean UES resting pressure
Time frame: baseline, during the intervention
Mean upper esophageal sphincter integrated relaxation pressure
Mean UES IRP 2 sec
Time frame: baseline, during the intervention
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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Time frame: during the intervention