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

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

Status: Active, not recruiting

Conditions: Non-Alcoholic Steatohepatitis (NASH); Diabetes Mellitus Type 2 (T2DM)

Treatments: Other: specialized food product based on ice cream 3; Other: specialized food product based on ice cream 2; Other: specialized food product based on ice cream

Study type: Interventional

Funder types: Other

Identifiers

NCT06724913

19-76-30014-P (Other Grant/Funding Number)

OGIG-19-76-30014/2024-1

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• willingness to participate based on signed written informed consent;
• controlled glycemia. If stable glycemia is achieved on treatment, the following requirements should be met:
• no qualitative changes in treatment within 6 months before enrollment (i.e., the introduction of a new antidiabetic therapy);
• doses of anti-diabetic medications should be stable for 6 month in patients who receive metformin, gliptins, sulfonylureas, sodium/glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 agonists (GLP-1) or insulin.
• no new medications during participation in the study

Exclusion criteria

• Pregnancy and breastfeeding;

• Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM > or = 14 kPa by Fibroscan), or APRI > or= 1; or BARD score > or = 2.

• Chronic heart failure (I-IV class by NYHA).

• Past bariatric surgery.

• Clinically relevant acute cardiovascular event within 6 months prior to screening.

• Uncontrolled arterial hypertension despite optimal antihypertensive therapy.

• Diabetes mellitus type 1.

• The level of glycated hemoglobin [HbA1c] >9.0%.

• Hypersensitivity to the studied product or any of its components.

• The intake of any medications that may affect the absorption, distribution, metabolism or excretion of investigational products or may lead to the induction or inhibition of microsomal enzymes (for example, indomethacin) - from the moment of randomization to the end of treatment.

• Any medical conditions that may significantly affect life expectancy, including known cancers;

• Any clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, tumor or psychiatric diseases;

• Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with the requirements of the study protocol.

• Positive HIV blood antigen test.

• Serum aspartate aminotransferase (AST) and/or ALT >10 x upper normal limits.

• conjugated bilirubin > 26 mcmol/l due to changes in liver function (patients with Gilbert's disease are allowed to the study).

  • The international normalized ratio is >1.40 due to changes in liver function.
  • Platelet count <100 x 10^9/L due to portal hypertension.
  • Clinically significant renal dysfunction, including nephrotic syndrome, chronic kidney disease (determined based on the estimated glomerular filtration rate [eGFR] less than 60 ml/min/1.73 m^2).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 3 patient groups

Arm 1

Experimental group

Description:

Subjects of this arm will receive the following sequence of products: day 1 - ice cream with brazzein, maltitol and oligofructose, day 2 - ice cream with brazzein, erythritol, maltitol and inulin; day 3 - standard ice cream

Treatment:

Other: specialized food product based on ice cream

Arm 2

Experimental group

Description:

Subjects of this arm will receive the following sequence of products: day 1 - ice cream with brazzein, erythritol, maltitol and inulin; day 2 - ice cream with brazzein, maltitol and oligofructose, day 3 - standard ice cream

Treatment:

Other: specialized food product based on ice cream 2

Arm 3

Experimental group

Description:

Subjects of this arm will receive the following sequence of products: day 1 - standard ice cream; day 2 - ice cream with brazzein, maltitol and oligofructose, day 3 - ice cream with brazzein, erythritol, maltitol and inulin

Treatment:

Other: specialized food product based on ice cream 3