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

Not Applicable

Recruiting

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

• Registration Number: NCT07121803
• Lead Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

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.

Study Timeline

• Study Start: 2025-07-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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
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 intrabolus pressure	baseline, during the intervention	IBP

Secondary Outcome Measures

Name	Time	Method
mean upper esophageal sphincter resting pressure	baseline, during the intervention	mean UES resting pressure
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 integrated relaxation pressure	baseline, during the intervention	Mean UES IRP 2 sec

Trial Locations

Locations (1)

Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.; 🇷🇺 Moscow, Russian Federation