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

NCT06724913 | Active Not Recruiting DMC

• 2 other identifiers: OGIG-19-76-30014/2024-119-76-30014-P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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)

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

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• product organoleptic assessment

  An organoleptic evaluation study phase

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Arm 3

EXPERIMENTAL

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

Interventions

specialized food product based on ice cream OTHER

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)

Also known as: ice cream with brazzein, maltitol and oligofructose, ice cream with brazzein, maltitol, inulin, erythritol, standard ice cream (sundae)

Arm 1

specialized food product based on ice cream 2 OTHER

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)

Arm 2

specialized food product based on ice cream 3 OTHER

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

Arm 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead
• Group of companies EFKO: collaborator
• Russian Science Foundation: collaborator

Study Sites (1)

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

Moscow, 115446, Russia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

Ice Cream; maltitol; oligofructose; Inulin; Erythritol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Sugar Alcohols; Alcohols; Organic Chemicals

Study Officials

• Vasily Isakov, MD, PhD, Professor

  Department of Gastroenterology, Hepatology and Nutrition. Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 9, 2024
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years after study completion

Locations

RU (1)