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)
An organoleptic evaluation study phase preceded the main active intervention phase of the study. During this phase, all three types of ice cream were evaluated using a 5-point hedonic scale (1 = dislike extremely, 3 = neither like nor dislike, 5 = like extremely) for overall impression, flavor, color, appearance, aroma, and texture. Portions of 100 g of the ice cream were used with proper labelling (three-digit code) for randomization and supporting crossover design. The evaluation was performed as one portion per day and organized due to technical reasons as two round evaluations, in which one round included standard ice cream and the 1st special product, and the second round included standard ice cream and the 2nd special product. There were 3 days washout period between rounds to prevent carryover effects between the tested products. The percentage of ice cream consumed was determined by weighing the remaining portion of each ice cream after testing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
100
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)
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)
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
Dpt Gastroenterology, Hepatology and Nutrition, Federal Research Centre of Nutrition and Biotechnology, Kashirskoye shosse, bld 21, Moscow, Russia.
Moscow, Russia
mean daily glucose change
mean blood glucose concentration based on monitoring system
Time frame: baseline and day 1
mean daily glucose change
Mean daily blood glucose concentrations based on monitoring system
Time frame: baseline and day 2
mean daily glucose change
Mean daily blood glucose concentrations based on monitoring system
Time frame: baseline and day 3
mean daily glucose change
Mean daily blood glucose concentrations based on monitoring system
Time frame: baseline and day 4
stool frequency
stool frequency (formal)
Time frame: baseline and day 1
stool frequency
stool frequency (formal)
Time frame: baseline and day 2
stool frequency
stool frequency (formal)
Time frame: baseline and day 3
stool frequency
stool frequency (formal)
Time frame: baseline and day 4
stool form
stool form according to Bristol stool scale
Time frame: baseline and day 1
stool form
stool form according to Bristol stool scale
Time frame: baseline and day 2
stool form
stool form according to Bristol stool scale
Time frame: baseline and day 3
stool form
stool form according to Bristol stool scale
Time frame: baseline and day 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.