Autoimmune Diseases
Conditions
Keywords
AI-guided dietary supplementation, Genetic profiling, Metabolic profiling, Disease reduction
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
Interventions
OTHERControl group
Participants receive supplement prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
OTHERAI-Guided Group
Participants receive supplement prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.
Sponsors
Triangel Scientific
Center of New Medical Technologies
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Percent change in specific symptoms of autoimmune disease | 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. |
| Number Participant adherence to the prescribed dietary supplements regimen | 6 months | — |
Countries
Russia
Outcome results
None listed