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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06448234
Enrollment
70
Registered
2024-06-07
Start date
2024-02-02
Completion date
2024-06-03
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

LDL cholesterol reduction, AI-guided prescriptions, Dietary supplements, Personalized nutrition

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.

Interventions

OTHERStandart supplementation therapy group

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

OTHERAI-guided supplementation therapy group

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

Sponsors

Center of New Medical Technologies
CollaboratorOTHER
S.LAB (SOLOWAYS)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
change in LDL-C180 days

Secondary

MeasureTime frame
Percent change in high-sensitivity C-reactive protein (180 days
Percent change in high-density lipoprotein cholesterol180 days
Percent change in total cholesterol.180 days
Percent change in serum triglycerides between the groups.180 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026