Metabolic Syndrome
Conditions
Keywords
AI-guided dietary supplementation, Metabolic parameters improvement, Genetic profiling, metabolic profiling
Brief summary
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.
Interventions
Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
OTHERAI-Guided Group
Participants receive DS prescriptions determined by GenAIS, is an AI system that considers genetic data, metabolic profiles, biochemical markers, and patient history.
Sponsors
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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 metabolic syndrome, defined by the presence of at least three of the following criteria: * Waist circumference \> 102 cm (men) or \> 88 cm (women). * Triglycerides ≥ 150 mg/dL. * HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women). * Blood pressure ≥ 130/85 mm Hg. * Fasting glucose ≥ 100 mg/dL. • Willingness to provide genetic and metabolic data.
Exclusion criteria
* Significant renal, hepatic, or cardiovascular diseases. * Use of dietary supplements that affect metabolic parameters within the last 3 months. * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Metabolic Syndrome Score | 6 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| High-Sensitivity C-Reactive Protein change | 6 months |
| Waist Circumference change in cm | 6 months |
| Triglycerides change in mg/dl | 6 months |
| HDL Cholesterol change in mg/dl | 6 months |
| Fasting Glucose in mg/dl | 6 months |
| Body Weight change in kg | 6 months |
| body mass index (BMI) change | 6 months |
| Incidence of any Adverse Effects | 6 months |
| Blood Pressure change in mmHg | 6 months |
Countries
Russia
Outcome results
None listed