How three ice-cream formulations affect esophageal movement in people with GERD or weak esophageal motility

Analysis of Effects of Specialized Food Products Based on Ice-Cream on Esophageal Motility

This test will try three specially made ice creams to see if they change how the esophagus moves in people with ineffective esophageal motility or GERD.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology (other)
• Locations: 1 site (Moscow)
• Trial ID: NCT07121803 on ClinicalTrials.gov

What this trial studies

Participants undergo high-resolution esophageal manometry following the Chicago IV protocol to measure esophageal motility. During the procedure each person receives three different food products in a randomized order: a standard ice-cream sundae, an ice cream containing brazzein with maltitol and oligofructose, and an ice cream containing brazzein with erythritol, maltitol and inulin. Tolerability and symptoms after each product are recorded using standardized scales and formal questionnaires. The study compares motility patterns and patient-reported tolerability across the three formulations.

Who should consider this trial

Good fit: Adults with diagnosed ineffective esophageal motility or GERD who can give informed consent, have controlled and stable glycemia without recent changes in antidiabetic therapy, and agree not to start new medications during the study are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have advanced liver disease, chronic heart failure, active diarrhea, or prior major abdominal or chest surgery are excluded and are unlikely to benefit from the interventions tested.

Why it matters

Potential benefit: If successful, this could identify ice-cream formulations that are better tolerated or that positively influence esophageal motility, offering simple dietary options to reduce symptoms.

How similar studies have performed: This approach is relatively novel and there is limited prior evidence directly testing ice-cream–based formulations on esophageal motility.

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.

Where this trial is running

Moscow

• Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia. — Moscow, Russia (RECRUITING)

Study contacts

• Principal investigator: Sergey Morozov, MD, PhD — Federal Research Center of Nutrition and Biotechnology
• Study coordinator: Sergey Morozov, MD, PhD

Conditions: Ineffective Esophageal Motility, GERD, Esophageal motility, Specialized foods, icecream, esophagus, motility, high-resolution esophageal manometry