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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06724913
• Lead Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Brief 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 and 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-01-15
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
mean daily glucose change	baseline and day 4	Mean daily blood glucose concentrations based on monitoring system
stool frequency	baseline and day 4	stool frequency (formal)
stool form	baseline and day 4	stool form according to Bristol stool scale
product organoleptic assessment	baseline and day 3	organoleptic assessment on taste, scent, colour and texture with the use of a special form based on visual-analogue scale