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

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)

Interventions

OTHER

specialized food product based on ice cream

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)

OTHER

specialized food product based on ice cream 2

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)

OTHER

specialized food product based on ice cream 3

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

Sponsors & Collaborators

• Group of companies EFKO

  collaborator UNKNOWN

• Russian Science Foundation

  collaborator OTHER

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

  lead OTHER

Principal Investigators

• Vasily Isakov, MD, PhD, Professor · Department of Gastroenterology, Hepatology and Nutrition. Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Russia

Study Locations