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Non-Alcoholic Steatohepatitis (NASH)NCT06724913

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

A study testing specialized food product based on ice cream, specialized food product based on ice cream 2 and specialized food product based on ice cream 3 in people with Non-Alcoholic Steatohepatitis (NASH) and Diabetes Mellitus Type 2 (T2DM), run by Federal State Budgetary Scientific Institution at 1 site in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
specialized food product based on ice cream, specialized food product based on ice cream 2 and specialized food product based on ice cream 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteRussia
Study dates
1 Jun 2025to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow, 115446

Other trials in Russia

About this study

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)

Read the 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.

Being tested
specialized food product based on ice cream, specialized food product based on ice cream 2, specialized food product based on ice cream 3
Keywords
ice cream, NASH, specialized food product, Diabetes mellitus type 2, tolerability, safety, oligofructose, erythritol, inulin, maltitol, blood glycemic monitoring, sundae, brazzein
Medical subject headings
Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • specialized food product based on ice creamOther

    Also called ice cream with brazzein, maltitol and oligofructose, ice cream with brazzein, maltitol, inulin, erythritol, standard ice cream (sundae)

    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)

  • specialized food product based on ice cream 2Other

    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)

  • specialized food product based on ice cream 3Other

    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

Study groups in NCT06724913
Study groupRoleWhat they receive
Arm 1ExperimentalSubjects 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
Receives: Other: specialized food product based on ice cream
Arm 2ExperimentalSubjects 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
Receives: Other: specialized food product based on ice cream 2
Arm 3ExperimentalSubjects 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
Receives: Other: specialized food product based on ice cream 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean daily glucose change

    mean blood glucose concentration based on monitoring system

    Measured: baseline and day 1

  2. mean daily glucose change

    Mean daily blood glucose concentrations based on monitoring system

    Measured: baseline and day 2

  3. mean daily glucose change

    Mean daily blood glucose concentrations based on monitoring system

    Measured: baseline and day 3

  4. mean daily glucose change

    Mean daily blood glucose concentrations based on monitoring system

    Measured: baseline and day 4

  5. stool frequency

    stool frequency (formal)

    Measured: baseline and day 1

  6. stool frequency

    stool frequency (formal)

    Measured: baseline and day 2

  7. stool frequency

    stool frequency (formal)

    Measured: baseline and day 3

  8. stool frequency

    stool frequency (formal)

    Measured: baseline and day 4

  9. stool form

    stool form according to Bristol stool scale

    Measured: baseline and day 1

  10. stool form

    stool form according to Bristol stool scale

    Measured: baseline and day 2

  11. stool form

    stool form according to Bristol stool scale

    Measured: baseline and day 3

  12. stool form

    stool form according to Bristol stool scale

    Measured: baseline and day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start1 Jun 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06724913
Sponsor's protocol ID
OGIG-19-76-30014/2024-1
Other IDs
19-76-30014-P
Status last verified
Dec 2025
First submitted
6 Dec 2024
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Depersonalized study data will be available upon reasonable request to principal investigator

Publications

  • Isakov VA, Pilipenko VI, Goncharov AA, Sasunova A. Effect of sucrose-free brazzein-sweetened ice cream on continuously monitored glycemic response in patients with metabolic dysfunction-associated steatotic liver disease: a randomized controlled double-blind crossover trial. Clin Nutr ESPEN. 2026 Aug 31:105066. doi: 10.1016/j.clnesp.2026.105066. Online ahead of print.

    PubMed 42674358

Questions about this trial

What is this clinical trial studying?

A study testing specialized food product based on ice cream, specialized food product based on ice cream 2 and specialized food product based on ice cream 3 in people with Non-Alcoholic Steatohepatitis (NASH) and Diabetes Mellitus Type 2 (T2DM), run by Federal State Budgetary Scientific Institution at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean daily glucose change (time frame: baseline and day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06724913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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