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

Launched by FEDERAL STATE BUDGETARY SCIENTIFIC INSTITUTION "FEDERAL RESEARCH CENTRE OF NUTRITION, BIOTECHNOLOGY · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two special types of ice cream to see if they can help people with non-alcoholic fatty liver disease (NASH) and type 2 diabetes (T2DM). The ice creams are made with ingredients like maltitol and inulin, which may be better for managing blood sugar levels compared to regular sundae ice cream. Participants in the study will eat a portion of these special ice creams for breakfast over three days, alongside their regular meals. Researchers will monitor how well these ice creams are tolerated and how they affect blood sugar levels using a continuous glucose monitoring system.

To be eligible for this study, participants need to be between the ages of 18 and 75, have stable blood sugar control, and be willing to provide consent to take part. They should not have serious liver problems, heart conditions, or other significant health issues. During the trial, participants will be asked questions about how they feel after eating the ice cream, and they’ll wear a device that tracks their blood sugar levels. This study is not yet recruiting participants, but it aims to find out if these special ice creams can be a helpful part of a diet for managing NASH and T2DM.

Gender

ALL

Eligibility criteria

• 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).