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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Mean lower esophageal sphincter resting pressure [Time frame: baseline, during the intervention]
• Distal contractile integral [Time frame: baseline, during the intervention]
• mean lower esophageal sphincter integral relaxation pressure [Time frame: baseline, during the intervention]
• Mean contractile front velocity [Time frame: baseline, during the intervention]
• Distal latency [Time frame: baseline, during the intervention]
• Mean intrabolus pressure [Time frame: baseline, during the intervention]

Secondary outcome measures (3)

• mean upper esophageal sphincter resting pressure [Time frame: baseline, during the intervention]
• Mean upper esophageal sphincter integrated relaxation pressure [Time frame: baseline, during the intervention]
• product organoleptic assessment [Time frame: during the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Basic science

Study locations

Russia · 1 center

• Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and B — Moscow

Identifiers

NCT: NCT07121803 · OGIG-2025-MICE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗