Personalized Management of Autoimmune Diseases With AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The percent change in disease activity scores for the AI-Guided group compared with the Control group
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The percent change in disease activity scores for the AI-Guided group compared with the Control group
时间窗: 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.
次要结局
- 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)
- Changes in quality of life score World Health Organization Quality of Life - BREF(6 months)