Actively Recruiting
The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility
Led by Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology · Updated on 2025-08-14
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
F
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Lead Sponsor
R
Russian Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to assess the influence of specialized products based on ice cream on esophageal motility
CONDITIONS
Official Title
The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to participate with signed informed consent
- Controlled blood sugar levels with stable treatment for at least 6 months
- No changes in anti-diabetic medication doses for 6 months if on specific diabetes treatments
- No new medications started during the study participation
You will not qualify if you...
- Pregnancy or breastfeeding
- Liver cirrhosis or related liver stiffness above specified thresholds
- Frequent watery diarrhea (more than 3 times a day)
- Chronic heart failure (NYHA class I-IV)
- Past major abdominal or chest surgery including bariatric procedures or fundoplication (except appendectomy or cholecystectomy over a year ago)
- Achalasia or esophago-gastric junction outflow obstruction
- Major esophageal motility disorders by Chicago IV classification
- Recent major cardiovascular events within 6 months before screening
- Uncontrolled high blood pressure despite treatment
- Type 1 diabetes mellitus
- Glycated hemoglobin above 9.0%
- Allergy or intolerance to study products or components, including lactose
- Use of medications affecting esophageal motility
- Serious medical conditions affecting life expectancy, including cancers
- Significant immunological, endocrine, blood, gastrointestinal, neurological, tumor, or psychiatric diseases
- Mental incapacity affecting consent or compliance
- Inability to tolerate high-resolution esophageal manometry without sedation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.
Moscow, Russia, 115446
Actively Recruiting
Research Team
S
Sergey Morozov, MD, PhD
CONTACT
A
Armida Sasunova, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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