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

NCT06448234 | Completed

• 1 other identifier: SW012
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change in LDL-C

  180 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Standart supplementation therapy group

AI-Guided Group

EXPERIMENTAL

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

Other: AI-guided supplementation therapy group

Interventions

Standart supplementation therapy group OTHER

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

Control Group

AI-guided supplementation therapy group OTHER

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

AI-Guided Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: February 2, 2024
• Primary Completion: May 15, 2024
• Study Completion: June 3, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

RU (1)