Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation
- Conditions
- Autoimmune Diseases
- Interventions
- Other: Control groupOther: AI-Guided Group
- Registration Number
- NCT06470412
- Lead Sponsor
- S.LAB (SOLOWAYS)
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Control group - AI-Guided Group AI-Guided Group -
- Primary Outcome Measures
Name Time Method The percent change in disease activity scores for the AI-Guided group compared with the Control group 6 months 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.
- Secondary Outcome Measures
Name Time Method 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 Changes in quality of life score Short Form-36 6 months 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.
Changes in quality of life score World Health Organization Quality of Life - BREF 6 months 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.
Trial Locations
- Locations (1)
Center of New Medical Technologies
🇷🇺Novosibirsk, Novosibisk Region, Russian Federation