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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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Primary endpoints: 15 to 12v3 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Sep 30, 2025 to Dec 31, 2025
    • Study description expanded, about 154 words
    • Site details revised
    • Study title expanded, about 2 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2025 to Jun 1, 2025
    • Study sites: 0 to 1
    • Primary completion date: Aug 31, 2025 to Sep 30, 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06724913
Lead Sponsor Federal State Budgetary Scientific Institution
Collaborators: EFKO Group, Russian Science Foundation
Conditions
(from sponsor)		 Non-Alcoholic Steatohepatitis (NASH), Diabetes Mellitus Type 2 (T2DM)
Related terms Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov