Hypercholesterolemia Clinical Trial
Official title:
Evaluating the Efficacy of AI-Guided vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients: A Randomized Controlled Pilot Trial
NCT number | NCT06448234 |
Other study ID # | SW012 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2, 2024 |
Est. completion date | June 3, 2024 |
Verified date | June 2024 |
Source | S.LAB (SOLOWAYS) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The trial compared AI-guided and standard physician-guided dietary supplement (DS) prescriptions for lowering LDL cholesterol (LDL-C) in hypercholesterolemic patients. The AI system used genetic, metabolic, and clinical data to personalize DS regimens, hypothesizing superior efficacy over traditional methods. This 3-month randomized, controlled trial involved adults aged 40-75 with specific LDL-C levels, excluding those with significant health risks. Participants were divided into a control group with physician-guided DS and an AI-guided group. The AI system from Triangel Scientific provided dynamic, personalized recommendations. Baseline and follow-up measurements included lipid profiles and adherence assessments. The AI-guided group showed significantly greater LDL-C reduction and improvement in other lipid markers. The study concluded that AI-guided DS prescriptions are more effective, suggesting a promising future for AI in personalized cholesterol management.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 3, 2024 |
Est. primary completion date | May 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age between 40 and 75 years. - LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form. Exclusion Criteria: - Personal history of cardiovascular disease or high risk (= 20%). - Triglycerides (TG) = 400 mg/dL. - Body Mass Index (BMI) = 35 kg/m² - Use of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months. - Diabetes mellitus. - Known severe or uncontrolled thyroid, liver, renal, or muscle diseases. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Center of New Medical Technologies | Novosibirsk | Novosibisk Region |
Lead Sponsor | Collaborator |
---|---|
S.LAB (SOLOWAYS) | Center of New Medical Technologies |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in LDL-C | 180 days | ||
Secondary | Percent change in high-sensitivity C-reactive protein ( | 180 days | ||
Secondary | Percent change in high-density lipoprotein cholesterol | 180 days | ||
Secondary | Percent change in total cholesterol. | 180 days | ||
Secondary | Percent change in serum triglycerides between the groups. | 180 days |
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