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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06448234
• Other study ID #: SW012
• Status: Completed
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: June 3, 2024

Study information

• Verified date: June 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• Standart supplementation therapy group
Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles
• 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.

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (2)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

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