AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome

AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome: A Randomized Controlled Study

The study "AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing metabolic syndrome. This 6-month randomized controlled trial included 160 participants diagnosed with metabolic syndrome. Participants were divided into two groups: one received DS based on physician judgment, and the other based on GenAIS AI system analysis. Primary outcomes focused on changes in metabolic parameters, while secondary outcomes included individual components of metabolic syndrome, inflammation levels, body weight, and adherence to the DS regimen. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Standard therapy group; Other: AI-Guided Group

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 40 and 75 years.
• Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
• Waist circumference > 102 cm (men) or > 88 cm (women).
• Triglycerides ≥ 150 mg/dL.
• HDL cholesterol < 40 mg/dL (men) or < 50 mg/dL (women).
• Blood pressure ≥ 130/85 mm Hg.
• Fasting glucose ≥ 100 mg/dL. • Willingness to provide genetic and metabolic data.

Exclusion Criteria:

• Significant renal, hepatic, or cardiovascular diseases.
• Use of dietary supplements that affect metabolic parameters within the last 3 months.
• Pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Metabolic Syndrome Score	This includes measuring and tracking changes in the five main components of metabolic syndrome: waist circumference, triglycerides, high-density lipoproteins ( HDL) cholesterol, blood pressure, and fasting glucose. These components are central to the definition of metabolic syndrome and are commonly used to assess the efficacy of interventions. The Composite Metabolic Syndrome Score combines multiple metabolic risk factors and typically ranges from 0 (optimal) to 5 (worst), with higher scores indicating a worse outcome.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Waist Circumference change in cm	6 months
Triglycerides change in mg/dl	6 months
HDL Cholesterol change in mg/dl	6 months
Blood Pressure change in mmHg	6 months
Fasting Glucose in mg/dl	6 months
High-Sensitivity C-Reactive Protein change	6 months
Body Weight change in kg	6 months
body mass index (BMI) change	6 months
Incidence of any Adverse Effects	6 months

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): June 5, 2024

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Genetic profiling; metabolic profiling; AI-guided dietary supplementation; Metabolic parameters improvement
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: SW017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No