NCT06470399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
Last Updated

April 11, 2025

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

June 17, 2024

Last Update Submit

April 8, 2025

Conditions

Metabolic Syndrome

Keywords

AI-guided dietary supplementationMetabolic parameters improvementGenetic profilingmetabolic profiling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR
Other: Standard therapy group

AI-Guided Group

EXPERIMENTAL
Other: AI-Guided Group

Interventions

Standard therapy groupOTHER

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

Control Group
AI-Guided GroupOTHER

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

AI-Guided Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional 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 17, 2024

First Posted

June 24, 2024

Study Start

February 2, 2023

Primary Completion

May 20, 2024

Study Completion

June 5, 2024

Last Updated

April 11, 2025

Record last verified: 2024-06

Locations

RU(1)