Clinical trial NCT06470412: Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation
Official title: Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Diseases
Keywords: AI-guided dietary supplementation
Genetic profiling
Metabolic profiling
Disease reduction
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Triangel Scientific
name: Center of New Medical Technologies
First posted: 2024-06-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The percent change in disease activity scores for the AI-Guided group compared with the Control group
timeFrame: 6 months
Secondary outcomes:
measure: Percent change in specific symptoms of autoimmune disease
timeFrame: 6 months
measure: Percent change in high-sensitivity C-reactive protein
timeFrame: 6 months
measure: Percent change in body weight and body mass index
timeFrame: 6 months
measure: Incidence of adverse effects related to dietary supplements.
timeFrame: 6 months
measure: Number Participant adherence to the prescribed dietary supplements regimen
timeFrame: 6 months
measure: Changes in quality of life score Short Form-36
timeFrame: 6 months
measure: Changes in quality of life score World Health Organization Quality of Life - BREF
timeFrame: 6 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References: