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

NCT06470412 | Completed

• 1 other identifier: SW015
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autoimmune Diseases

Keywords

AI-guided dietary supplementation; Genetic profiling; Metabolic profiling; Disease reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Incidence of adverse effects related to dietary supplements.

  6 months

• Number Participant adherence to the prescribed dietary supplements regimen

  6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Other: Control group

AI-Guided Group

EXPERIMENTAL

Other: AI-Guided Group

Interventions

Control group OTHER

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

Control Group

AI-Guided Group OTHER

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

AI-Guided Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Triangel Scientific: collaborator
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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 30, 2024
• Study Completion: June 10, 2024
• Last Updated: April 11, 2025

Record last verified: 2024-06

Locations

RU (1)