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

NCT07121803 | Recruiting DMC

• 1 other identifier: OGIG-2025-MICE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ineffective Esophageal Motility; GERD (Gastroesophageal Reflux Disease)

Keywords

Esophageal motility; Specialized foods; icecream; esophagus; motility; high-resolution esophageal manometry

Outcome Measures

Primary Outcomes (6)

• Mean lower esophageal sphincter resting pressure

  Based on the high-resolution esophageal manometry measurement

  baseline, during the intervention

• Distal contractile integral

  baseline, during the intervention

• mean lower esophageal sphincter integral relaxation pressure

  IRP 4

  baseline, during the intervention

• Mean contractile front velocity

  CFV

  baseline, during the intervention

• Distal latency

  DL

  baseline, during the intervention

• Mean intrabolus pressure

  IBP

  baseline, during the intervention

Secondary Outcomes (3)

• mean upper esophageal sphincter resting pressure

  baseline, during the intervention

• Mean upper esophageal sphincter integrated relaxation pressure

  baseline, during the intervention

• product organoleptic assessment

  during the intervention

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Other: specialized food based on ice cream, order 1

Arm 2

EXPERIMENTAL

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

Other: specialized food based on ice cream, order 2

Arm 3

EXPERIMENTAL

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

Other: specialized food based on ice cream, order 3

Interventions

specialized food based on ice cream, order 1 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)

Also known as: 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)

Arm 1

specialized food based on ice cream, order 2 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 2

specialized food based on ice cream, order 3 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

Arm 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead
• Russian Science Foundation: collaborator
• Group of companies EFKO: collaborator

Study Sites (1)

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

Moscow, 115446, Russia

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Ice Cream; maltitol; oligofructose; Inulin; Erythritol

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Sugar Alcohols; Alcohols; Organic Chemicals

Study Officials

• Sergey Morozov, MD, PhD

  Federal Research Center of Nutrition and Biotechnology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey Morozov, MD, PhD

CONTACT

4996131091; 84996131091@mail.ru

Armida Sasunova, MD

CONTACT

4996131091; armida.sasunova@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a double-blind cross-over study

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 14, 2025
• Study Start: July 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: within 2 years upon study completion
• Access Criteria: Qualified persons who applied reasonable request to access the data. According to the local law, only depersonalized data may be shared.

Locations

RU (1)