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

NCT ID: NCT07121803

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Ineffective Esophageal Motility; GERD (Gastroesophageal Reflux Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

specialized food based on ice cream, order 1

Intervention Type: OTHER

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)

Arm 2

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

Group Type: EXPERIMENTAL

specialized food based on ice cream, order 2

Intervention Type: OTHER

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)

Arm 3

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

Group Type: EXPERIMENTAL

specialized food based on ice cream, order 3

Intervention Type: OTHER

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

Interventions

specialized 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)

Intervention Type: OTHER

specialized 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)

Intervention Type: OTHER

specialized 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

Intervention Type: OTHER

Other Intervention Names

specialized food product based on ice cream; ice cream with brazzein, maltitol and oligofructose; ice cream with brazzein, maltitol, inulin, erythritol; standard ice cream (sundae)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Russian Science Foundation

OTHER

Sponsor Role: collaborator

Group of companies EFKO

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Sergey Morozov

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergey Morozov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal Research Center of Nutrition and Biotechnology

Locations

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

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Sergey Morozov, MD, PhD

Role: CONTACT

84996131091@mail.ru

4996131091

Armida Sasunova, MD

Role: CONTACT

armida.sasunova@yandex.ru

4996131091

Facility Contacts

Sergey Morozov, MD, PhD

Role: primary

morosoffsv@mail.ru

9104681801

Armida Sasunova, MD

Role: backup

84996131091@mail.ru

4996131091

Other Identifiers

OGIG-2025-MICE

Identifier Type: -

Identifier Source: org_study_id