Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Lowering LDL Cholesterol in Hypercholesterolemic Patients

S.LAB (SOLOWAYS)

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Other: AI-guided supplementation therapy group; Other: Standart supplementation therapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT06448234

SW012

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.

Treatment:

Other: Standart supplementation therapy group

AI-Guided Group

Experimental group

Description:

Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Treatment:

Other: AI-guided supplementation therapy group