Ice cream as medicine? study tests sweet treat for fatty liver and diabetes

NCT ID NCT06724913

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether special ice creams made with natural sweeteners (brazzein, maltitol, erythritol, and fibers) can help control blood sugar and be easier on digestion than regular ice cream. One hundred adults with non-alcoholic fatty liver disease and type 2 diabetes will try three different ice creams on separate days. Researchers will monitor blood sugar continuously and ask about bowel habits to see which ice cream is best tolerated.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
special ice cream with brazzein, maltitol, oligofructose, erythritol, and inulin
What this could lead to
If it works, this could point toward a tasty, diet-friendly option to help manage blood sugar in people with fatty liver and diabetes.
What could go wrong
This is a very small, early study (100 people) testing ice cream over just 3 days. It only looks at short-term blood sugar and digestion, not long-term health or disease reversal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Moscow, 115446, Russia

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