Diabetes
Conditions
Keywords
AI-guided dietary supplementation, Personalized supplementation, HbA1c reduction, Genetic and metabolic profiling
Brief summary
This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.
Interventions
OTHERThe standard practice dietary supplements intervention
Participants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
OTHERThe AI-guided practice dietary supplements group
Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.
Sponsors
Triangel Scientific
Center of New Medical Technologies
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 40 and 75 years. * Diagnosed with Type 2 diabetes (HbA1c between 7.0% and 10.0%). * Stable anti-diabetic medication regimen for at least 3 months prior to the study. * Willingness to provide genetic and metabolic data.
Exclusion criteria
* Type 1 diabetes or other specific types of diabetes. * Significant renal, hepatic, or cardiovascular diseases. * Use of dietary supplements that affect glucose metabolism within the last 3 months. * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels | 180 days |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in high-sensitivity C-reactive protein | 180 days |
| Percent change in cholesterol | 180 days |
| Percent change in HDL-C, | 180 days |
| Percent change in LDL-C | 180 days |
| Percent change in triglycerides | 180 days |
| Percent change in body weight | 180 days |
| Incidence of any adverse effects related to supplements | 180 days |
| Percent change in Body mass index (BMI) | 180 days |
| Percent change in fasting venous blood glucose levels. | 180 days |
| fasting insulin levels change (mU/mL) | 180 days |
| Waist Circumference (cm) change | 180 days |
| microalbuminuria (%) difference | 180 days |
| changes in physical activity levels (hours/week) | 180 days |
| Percentage of participants using antihypertensive medications (%) | 180 days |
| Percentage of participants using antihypertensive medications (%). | 180 days |
| Percentage of participants using lipid-lowering medications (%). | 180 days |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 180 days |
Countries
Russia
Outcome results
None listed