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The study "AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing metabolic syndrome. This 6-month randomized controlled trial included 160 participants diagnosed with metabolic syndrome. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in metabolic parameters, while secondary outcomes included individual components of metabolic syndrome, inflammation levels, body weight, and adherence to the DS regimen. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator |
| |
| AI-Guided Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard therapy group | Other | Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Metabolic Syndrome Score | This includes measuring and tracking changes in the five main components of metabolic syndrome: waist circumference, triglycerides, high-density lipoproteins ( HDL) cholesterol, blood pressure, and fasting glucose. These components are central to the definition of metabolic syndrome and are commonly used to assess the efficacy of interventions. The Composite Metabolic Syndrome Score combines multiple metabolic risk factors and typically ranges from 0 (optimal) to 5 (worst), with higher scores indicating a worse outcome. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference change in cm | 6 months | |
| Triglycerides change in mg/dl | 6 months | |
| HDL Cholesterol change in mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of New Medical Technologies | Novosibirsk | Novosibisk Region | 630090 | Russia |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| AI-Guided Group | Other | Participants receive DS prescriptions determined by GenAIS, is an AI system that considers genetic data, metabolic profiles, biochemical markers, and patient history. |
|
| 6 months |
| Blood Pressure change in mmHg | 6 months |
| Fasting Glucose in mg/dl | 6 months |
| High-Sensitivity C-Reactive Protein change | 6 months |
| Body Weight change in kg | 6 months |
| body mass index (BMI) change | 6 months |
| Incidence of any Adverse Effects | 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |