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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Other: Standart supplementation therapy group; Other: AI-guided supplementation therapy group

• Registration Number: NCT06448234
• Lead Sponsor: S.LAB (SOLOWAYS)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Primary Completion: 2024-05-15
• Status Verified: 2024-06
• Study Completion: 2024-06-03
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-07
• Last Update Submitted: 2024-06-09
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standart supplementation therapy group	Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
AI-Guided Group	AI-guided supplementation therapy group	Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Primary Outcome Measures

Name	Time	Method
change in LDL-C	180 days

Secondary Outcome Measures

Name	Time	Method
Percent change in high-sensitivity C-reactive protein (	180 days
Percent change in high-density lipoprotein cholesterol	180 days
Percent change in total cholesterol.	180 days
Percent change in serum triglycerides between the groups.	180 days

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation