Clinical Trial

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

Active, Not Recruiting
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Record status
This record was last updated December 18, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-12-06; most recent amendment 2025-12-11.
Status change: Recruiting → Active, Not Recruiting 2025-12-11
Status change: Not Yet Recruiting → Recruiting 2025-08-01
Trial Details
NCT Number NCT06724913
Lead Sponsor Federal State Budgetary Scientific Institution
Collaborators: EFKO Group, Russian Science Foundation
Conditions Non-Alcoholic Steatohepatitis (NASH), Diabetes Mellitus Type 2 (T2DM)
Enrollment 100 participants
Start Date 2025-06-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-18