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

June 9, 2024 updated by: S.LAB (SOLOWAYS)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Novosibisk Region
      • Novosibirsk, Novosibisk Region, Russian Federation, 630090
        • Center of New Medical Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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
Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles
Experimental: AI-Guided Group
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
Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in LDL-C
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in high-sensitivity C-reactive protein (
Time Frame: 180 days
180 days
Percent change in high-density lipoprotein cholesterol
Time Frame: 180 days
180 days
Percent change in total cholesterol.
Time Frame: 180 days
180 days
Percent change in serum triglycerides between the groups.
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.LAB (SOLOWAYS)

Collaborators

Center of New Medical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

June 3, 2024

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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