NCT07121803

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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)

Interventions

Type	Name	Description
OTHER	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)
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)
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

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: Russia