NCT06724913View on ClinicalTrials.gov

Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice Cream (Ice Cream With Maltitol and Oligofructose; Ice Cream With Erythritol, Maltitol and Inulin) Compared to Standard (Sundae) Ice Cream

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2025

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

Trial Locations (1)

115446

RECRUITING

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

All Listed Sponsors
collaborator

Group of companies EFKO

UNKNOWN

collaborator

Russian Science Foundation

OTHER

lead

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

OTHER