Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice Cream (Ice Cream With Brazzein, Maltitol and Oligofructose; Ice Cream With Brazzein, Erythritol, Maltitol and Inulin) Compared to Standard (Sundae) Ice Cream

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 with or without 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)

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus Type 2 (T2DM); Non-Alcoholic Steatohepatitis (NASH)
• Intervention / Treatment: Other: specialized food product based on ice cream; Other: specialized food product based on ice cream 2; Other: specialized food product based on ice cream 3

Detailed Description

An organoleptic evaluation study phase preceded the main active intervention phase of the study. During this phase, all three types of ice cream were evaluated using a 5-point hedonic scale (1 = dislike extremely, 3 = neither like nor dislike, 5 = like extremely) for overall impression, flavor, color, appearance, aroma, and texture. Portions of 100 g of the ice cream were used with proper labelling (three-digit code) for randomization and supporting crossover design. The evaluation was performed as one portion per day and organized due to technical reasons as two round evaluations, in which one round included standard ice cream and the 1st special product, and the second round included standard ice cream and the 2nd special product. There were 3 days washout period between rounds to prevent carryover effects between the tested products. The percentage of ice cream consumed was determined by weighing the remaining portion of each ice cream after testing.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 115446
    • Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Subjects of this arm will receive the following sequence of products: day 1 - ice cream with brazzein, maltitol and oligofructose, day 2 - ice cream with brazzein, erythritol, maltitol and inulin; day 3 - standard ice cream	Other: specialized food product based on ice cream; Day 1: ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose Day 2: ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin Day 3: standard ice cream (12% fat); Other Names: ice cream with brazzein, maltitol and oligofructose; ice cream with brazzein, maltitol, inulin, erythritol; standard ice cream (sundae)
Experimental: Arm 2; Subjects of this arm will receive the following sequence of products: day 1 - ice cream with brazzein, erythritol, maltitol and inulin; day 2 - ice cream with brazzein, maltitol and oligofructose, day 3 - standard ice cream	Other: specialized food product based on ice cream 2; Day 1: ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin Day 2: ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose Day 3: standard ice cream (12% fat)
Experimental: Arm 3; Subjects of this arm will receive the following sequence of products: day 1 - standard ice cream; day 2 - ice cream with brazzein, maltitol and oligofructose, day 3 - ice cream with brazzein, erythritol, maltitol and inulin	Other: specialized food product based on ice cream 3; Day 1: standard ice cream (12% fat) Day 2: ice cream with 0.014% brazzein, 6% maltitol and 8% oligofructose Day 3: ice cream with 0.014% brazzein, 7.5% erythritol, 2.5% maltitol and 4% inulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean daily glucose change	mean blood glucose concentration based on monitoring system	baseline and day 1
mean daily glucose change	Mean daily blood glucose concentrations based on monitoring system	baseline and day 2
mean daily glucose change	Mean daily blood glucose concentrations based on monitoring system	baseline and day 3
mean daily glucose change	Mean daily blood glucose concentrations based on monitoring system	baseline and day 4
stool frequency	stool frequency (formal)	baseline and day 1
stool frequency	stool frequency (formal)	baseline and day 2
stool frequency	stool frequency (formal)	baseline and day 3
stool frequency	stool frequency (formal)	baseline and day 4
stool form	stool form according to Bristol stool scale	baseline and day 1
stool form	stool form according to Bristol stool scale	baseline and day 2
stool form	stool form according to Bristol stool scale	baseline and day 3
stool form	stool form according to Bristol stool scale	baseline and day 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
product organoleptic assessment	5-point hedonic scale (1 = dislike extremely, 3 = neither like nor dislike, 5 = like extremely) for overall impression, flavor, color, appearance, aroma, and texture	An organoleptic evaluation study phase

Collaborators and Investigators

• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Collaborators: Russian Science Foundation; Group of companies EFKO
• Investigators: Study Chair: Vasily Isakov, MD, PhD, Professor, Department of Gastroenterology, Hepatology and Nutrition. Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: tolerability; safety; NASH; ice cream; erythritol; inulin; oligofructose; Diabetes mellitus type 2; specialized food product; maltitol; blood glycemic monitoring; sundae; brazzein
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Liver Diseases; Fatty Liver; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Organic Chemicals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Polymers; Macromolecular Substances; Alcohols; Polysaccharides; Dairy Products; Starch; Glucans; Biopolymers; Fructans; Sugar Alcohols; Erythritol; Inulin; oligofructose; Ice Cream; maltitol
• Other Study ID Numbers: OGIG-19-76-30014/2024-1; 19-76-30014-P (Other Grant/Funding Number: Russian Science Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Depersonalized study data will be available upon reasonable request to principal investigator
• IPD Sharing Time Frame: 5 years after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No