Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation

Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study

The study "Personalized Management of Autoimmune Diseases with AI-Guided (GenAIS TM) Dietary Supplementation" investigated the effectiveness of AI-guided dietary supplement (DS) prescriptions compared to standard physician-guided prescriptions in managing autoimmune diseases. This 6-month randomized controlled trial included 160 participants with conditions like rheumatoid arthritis, lupus, and multiple sclerosis. 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 disease activity, while secondary outcomes included quality of life, metabolic markers, and DS adherence. Data collection involved genetic, metabolic, and clinical profiling, with ethical considerations ensuring participant confidentiality and informed consent

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Other: Control 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:

• Diagnosed with an autoimmune disease (e.g., rheumatoid arthritis, lupus, multiple sclerosis) according to established clinical criteria.
• Moderate to severe disease activity as indicated by standardized measures (e.g., DAS28 for rheumatoid arthritis, SLEDAI for lupus).
• Stable on existing autoimmune medication regimen for at least 3 months prior to the study.
• Willingness to provide genetic and metabolic data.
• Written informed consent.

Exclusion Criteria:

• Current or past history of severe psychiatric conditions or other severe chronic diseases.
• Significant medical conditions like severe renal, hepatic, or cardiovascular diseases that may interfere with the study outcomes.
• Use of dietary supplements that affect immune function within the last 3 months.
• Pregnancy or breastfeeding.
• Recent changes in autoimmune medication within the last 3 months.
• Participation in another clinical trial within the last 30 days.

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: Control 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	Other: AI-Guided Group; Participants receive supplement prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percent change in disease activity scores for the AI-Guided group compared with the Control group	Systemic Lupus Erythematosus Disease Activity Index, which has a score range from 0 to 105, to measure disease activity in participants with lupus. Disease Activity Score 28 (DAS28), which has a score range from 0 to 10, to measure disease activity in participants with rheumatoid arthritis.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse effects related to dietary supplements.		6 months
Percent change in specific symptoms of autoimmune disease		6 months
Percent change in high-sensitivity C-reactive protein		6 months
Percent change in body weight and body mass index		6 months
Number Participant adherence to the prescribed dietary supplements regimen		6 months
Changes in quality of life score Short Form-36	Short Form-36 Health Survey, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better health and well-being.	6 months
Changes in quality of life score World Health Organization Quality of Life - BREF	World Health Organization Quality of Life - BREF, which has a score range from 0 to 100, to measure the quality of life in participants, with higher scores indicating better quality of life.	6 months

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center of New Medical Technologies; Triangel Scientific

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): June 10, 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; Disease reduction
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: SW015

Drug and device information, study documents

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