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Completed

NCT Number: NCT06470399

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard therapy group

Other

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

AI-Guided Group

Other

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

Primary outcomes

  1. Composite Metabolic Syndrome Score

    Time frame: 6 months

    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.

Secondary outcomes

  1. Waist Circumference change in cm

    Time frame: 6 months

  2. Triglycerides change in mg/dl

    Time frame: 6 months

  3. HDL Cholesterol change in mg/dl

    Time frame: 6 months

  4. Blood Pressure change in mmHg

    Time frame: 6 months

  5. Fasting Glucose in mg/dl

    Time frame: 6 months

  6. High-Sensitivity C-Reactive Protein change

    Time frame: 6 months

  7. Body Weight change in kg

    Time frame: 6 months

  8. body mass index (BMI) change

    Time frame: 6 months

  9. Incidence of any Adverse Effects

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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