Analysis of Effects of Specialized Food Products Based on Ice-Cream on Esophageal Motility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean contractile front velocity
研究概览
简要总结
This study aims to assess the influence of specialized products based on ice cream on esophageal motility
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 =
- •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
- •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.
研究组 & 干预措施
Arm 1
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
干预措施: specialized food based on ice cream, order 1 (Other)
Arm 2
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
干预措施: specialized food based on ice cream, order 2 (Other)
Arm 3
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
干预措施: specialized food based on ice cream, order 3 (Other)
结局指标
主要结局
Mean contractile front velocity
时间窗: baseline, during the intervention
CFV
Mean intrabolus pressure
时间窗: baseline, during the intervention
IBP
Mean lower esophageal sphincter resting pressure
时间窗: baseline, during the intervention
Based on the high-resolution esophageal manometry measurement
Distal contractile integral
时间窗: baseline, during the intervention
mean lower esophageal sphincter integral relaxation pressure
时间窗: baseline, during the intervention
IRP 4
Distal latency
时间窗: baseline, during the intervention
DL
次要结局
- mean upper esophageal sphincter resting pressure(baseline, during the intervention)
- product organoleptic assessment(during the intervention)
- Mean upper esophageal sphincter integrated relaxation pressure(baseline, during the intervention)
研究者
Sergey Morozov
Principal Investigator
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology