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

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Status: Enrolling

Conditions: GERD (Gastroesophageal Reflux Disease); Ineffective Esophageal Motility

Treatments: Other: specialized food based on ice cream, order 1; Other: specialized food based on ice cream, order 3; Other: specialized food based on ice cream, order 2

Study type: Interventional

Funder types: Other

Identifiers

NCT07121803

OGIG-2025-MICE

Details and patient eligibility

About

This study aims to assess the influence of specialized products based on ice cream on esophageal motility

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Arm 1

Experimental group

Description:

Subjects of this arm will receive the following sequence of products: 1 - ice cream with brazzein, maltitol and oligofructose, 2 - ice cream with brazzein, erythritol, maltitol and inulin; 3 - standard ice cream

Treatment:

Other: specialized food based on ice cream, order 1

Arm 2

Experimental group

Description:

Subjects of this arm will receive the following sequence of products: 1 - ice cream with brazzein, erythritol, maltitol and inulin; 2 - ice cream with brazzein, maltitol and oligofructose, 3 - standard ice cream

Treatment:

Other: specialized food based on ice cream, order 2

Arm 3

Experimental group

Description:

Subjects of this arm will receive the following sequence of products: 1 - standard ice cream; 2 - ice cream with brazzein, maltitol and oligofructose, 3 - ice cream with brazzein, erythritol, maltitol and inulin

Treatment:

Other: specialized food based on ice cream, order 3