NCT06448234Completed
Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients
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
Source: ClinicalTrials.gov · Last updated 11 Jun 2024
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 3 Jun 2024
- Start date
- 2 Feb 2024
- Primary completion date
- 15 May 2024
- Lead sponsor
- S.LAB (SOLOWAYS)
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06448234
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 2 Feb 2024 to the primary completion date, 15 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center of New Medical Technologies Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.