Ineffective Esophageal MotilityMICENCT07121803
The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility
A study testing specialized food based on ice cream, order 1, specialized food based on ice cream, order 2 and specialized food based on ice cream, order 3 in people with Ineffective Esophageal Motility and GERD (Gastroesophageal Reflux Disease), run by Federal State Budgetary Scientific Institution at 1 site in Russia.
Trial summary
This study aims to assess the influence of specialized products based on ice cream on esophageal motility Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ineffective Esophageal Motility, GERD (Gastroesophageal Reflux Disease)
- What is being tested?
- specialized food based on ice cream, order 1, specialized food based on ice cream, order 2 and specialized food based on ice cream, order 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.
Moscow, 115446
Sergey Morozov, MD, PhD, 9104681801, morosoffsv@mail.ru
Armida Sasunova, MD, 4996131091, 84996131091@mail.ru
About this study
Official title: Analysis of Effects of Specialized Food Products Based on Ice-Cream on Esophageal Motility
This study aims to assess the influence of specialized products based on ice cream on esophageal motility
Read the 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.
- Being tested
- specialized food based on ice cream, order 1, specialized food based on ice cream, order 2, specialized food based on ice cream, order 3
- Keywords
- Esophageal motility, Specialized foods, icecream, esophagus, motility, high-resolution esophageal manometry
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specialized food based on ice cream, order 1Other
Also called 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)
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)
specialized food based on ice cream, order 2Other
- ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin;
- ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose;
- standard ice cream (12% fat)
specialized food based on ice cream, order 3Other
- standard ice cream (12% fat)
- ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose
- ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: specialized food based on ice cream, order 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean lower esophageal sphincter resting pressure
Based on the high-resolution esophageal manometry measurement
Measured: baseline, during the intervention
Distal contractile integral
Measured: baseline, during the intervention
mean lower esophageal sphincter integral relaxation pressure
IRP 4
Measured: baseline, during the intervention
Mean contractile front velocity
CFV
Measured: baseline, during the intervention
Distal latency
DL
Measured: baseline, during the intervention
Mean intrabolus pressure
IBP
Measured: baseline, during the intervention
Secondary outcomes (3)
mean upper esophageal sphincter resting pressure
mean UES resting pressure
Measured: baseline, during the intervention
Mean upper esophageal sphincter integrated relaxation pressure
Mean UES IRP 2 sec
Measured: baseline, during the intervention
product organoleptic assessment
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)
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Jul 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ineffective Esophageal MotilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a double-blind cross-over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Collaborators
- Russian Science Foundation, EFKO Group
- Responsible party
- Principal investigator, Sergey Morozov, Federal State Budgetary Scientific Institution
- Investigators
- Sergey Morozov, MD, PhD, Principal investigator, Federal Research Center of Nutrition and Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121803
- Sponsor's protocol ID
- OGIG-2025-MICE
- Acronym
- MICE
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD may be shared upon reasonable request to PI