Clinical trial NCT06724913: Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice Cream (ice Cream with Maltitol and Oligofructose; Ice Cream with Erythritol, Maltitol and Inulin) Compared to Standard (sundae) Ice Cream
Official title: Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice Cream (ice Cream with Maltitol and Oligofructose; Ice Cream with Erythritol, Maltitol and Inulin) Compared to Standard (sundae) Ice Cream
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Diabetes Mellitus Type 2 (T2DM)
Keywords: ice cream
NASH
specialized food product
Diabetes mellitus type 2
tolerability
safety
oligofructose
erythritol
inulin
maltitol
blood glycemic monitoring
sundae
brazzein
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
Collaborators: name: Group of companies EFKO
name: Russian Science Foundation
First posted: 2024-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a double-blind, randomized, comparative controlled cross-over study of efficacy and tolerability of 2 specialized food products based on ice cream compared to the standard (sundae) ice cream for patients with non-alcoholic fatty liver disease and type 2 diabetes mellitus. On 3 consecutive days eligible subjects will receive a portion of specialized food products with breakfast (ice cream with brazzein, maltitol and oligofructose; ice cream with brazzein, erythritol, maltitol and inulin; standard ice cream (sundae)) followed by the standard ration. Tolerability will be assessed based on specialized scales and formal questioning. Glucose monitoring will be performed with the use of prolonged blood glucose monitoring system (FreeStyle Libre 2, Abbott Diabetes Care, USA)


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.
* Chronic heart failure (I-IV class by NYHA).
* Past bariatric surgery.
* Clinically relevant acute cardiovascular event within 6 months prior to screening.
* Uncontrolled arterial hypertension despite optimal antihypertensive therapy.
* Diabetes mellitus type 1.
* The level of glycated hemoglobin \[HbA1c\] \>9.0%.
* Hypersensitivity to the studied product or any of its components.
* The intake of any medications that may affect the absorption, distribution, metabolism or excretion of investigational products or may lead to the induction or inhibition of microsomal enzymes (for example, indomethacin) - from the moment of randomization to the end of treatment.
* 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.
* Positive HIV blood antigen test.
* Serum aspartate aminotransferase (AST) and/or ALT \>10 x upper normal limits.
* conjugated bilirubin \> 26 mcmol/l due to changes in liver function (patients with Gilbert's disease are allowed to the study).

  * The international normalized ratio is \>1.40 due to changes in liver function.
  * Platelet count \<100 x 10\^9/L due to portal hypertension.
  * Clinically significant renal dysfunction, including nephrotic syndrome, chronic kidney disease (determined based on the estimated glomerular filtration rate \[eGFR\] less than 60 ml/min/1.73 m\^2).

Primary outcomes:
measure: mean daily glucose change
timeFrame: baseline and day 1
measure: mean daily glucose change
timeFrame: baseline and day 2
measure: mean daily glucose change
timeFrame: baseline and day 3
measure: mean daily glucose change
timeFrame: baseline and day 4
measure: stool frequency
timeFrame: baseline and day 1
measure: stool frequency
timeFrame: baseline and day 2
measure: stool frequency
timeFrame: baseline and day 3
measure: stool frequency
timeFrame: baseline and day 4
measure: stool form
timeFrame: baseline and day 1
measure: stool form
timeFrame: baseline and day 2
measure: stool form
timeFrame: baseline and day 3
measure: stool form
timeFrame: baseline and day 4
measure: product organoleptic assessment
timeFrame: baseline and day 1
measure: product organoleptic assessment
timeFrame: baseline and day 2
measure: product organoleptic assessment
timeFrame: baseline and day 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gastroenterology, Hepatology and Nutrition. Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia
name: Vasily Isakov, MD, PhD, Professor
role: STUDY_CHAIR
References: