GERD (Gastroesophageal Reflux Disease), Ineffective Esophageal Motility
Conditions
Keywords
Esophageal motility, Specialized foods, icecream, esophagus, motility, high-resolution esophageal manometry
Brief summary
This study aims to assess the influence of specialized products based on ice cream on esophageal motility
Detailed description
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.
Interventions
OTHERspecialized food based on ice cream, order 1
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)
OTHERspecialized food based on ice cream, order 2
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)
OTHERspecialized food based on ice cream, order 3
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
Sponsors
Russian Science Foundation
Group of companies EFKO
Federal State Budgetary Scientific Institution Federal Research Centre of Nutrition, Biotechnology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a double-blind cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* willingness to participate based on signed written informed consent; * controlled glycemia. If stable glycemia is achieved on treatment, the following requirements should be met: * 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
Exclusion criteria
* 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). * Past major abdominal or chest surgery, including bariatric procedures and fundoplication (except appendectomy or cholecystectomy performed more than a year before enrollment). * Achalasia and esophago-gastric junction outflow obstruction * Major esophageal motility disorders according to Chicago IV classification. * Clinically relevant acute cardiovascular event within 6 months prior to screening. * Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy. * Diabetes mellitus type 1. * The level of glycated hemoglobin \[HbA1c\] \>9.0%. * Hypersensitivity to the studied product or any of its components, including lactose intolerance. * The intake of any pharmaceutical agents with known influence on esophageal motility (including, but not limited to: beta-blockers, calcium channel blockers, m-cholinoblockers, myorelaxants, antidepressants, tranquilizers, prokinetic agents) * Any medical conditions that may significantly affect life expectancy, including known cancers; * Any clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, tumor or psychiatric diseases; * Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with the requirements of the study protocol; * Inability to tolerate high-resolution esophageal manometry without sedation, at least in part.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean intrabolus pressure | baseline, during the intervention | IBP |
| mean lower esophageal sphincter integral relaxation pressure | baseline, during the intervention | IRP 4 |
| Mean contractile front velocity | baseline, during the intervention | CFV |
| Distal latency | baseline, during the intervention | DL |
| Mean lower esophageal sphincter resting pressure | baseline, during the intervention | Based on the high-resolution esophageal manometry measurement |
| Distal contractile integral | baseline, during the intervention | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean upper esophageal sphincter integrated relaxation pressure | baseline, during the intervention | Mean UES IRP 2 sec |
| product organoleptic assessment | during the intervention | 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) |
| mean upper esophageal sphincter resting pressure | baseline, during the intervention | mean UES resting pressure |
Countries
Russia
Contacts
Primary ContactSergey Morozov, MD, PhD
Backup ContactArmida Sasunova, MD
Outcome results
None listed