AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome: 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
- Composite Metabolic Syndrome Score
研究概览
简要总结
The study "AI-Guided (GenAIS TM) Versus Standard Physician-Guided Dietary Supplementation for Managing Metabolic Syndrome" aimed to compare the effectiveness of AI-guided dietary supplement (DS) prescriptions versus standard physician-guided prescriptions in managing metabolic syndrome. This 6-month randomized controlled trial included 160 participants diagnosed with metabolic syndrome. 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 metabolic parameters, while secondary outcomes included individual components of metabolic syndrome, inflammation levels, body weight, and adherence to the DS regimen. 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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75 years.
- •Diagnosed with metabolic syndrome, defined by the presence of at least three of the following criteria:
- •Waist circumference > 102 cm (men) or > 88 cm (women).
- •Triglycerides ≥ 150 mg/dL.
- •HDL cholesterol < 40 mg/dL (men) or < 50 mg/dL (women).
- •Blood pressure ≥ 130/85 mm Hg.
- •Fasting glucose ≥ 100 mg/dL. • Willingness to provide genetic and metabolic data.
排除标准
- •Significant renal, hepatic, or cardiovascular diseases.
- •Use of dietary supplements that affect metabolic parameters within the last 3 months.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Composite Metabolic Syndrome Score
时间窗: 6 months
This includes measuring and tracking changes in the five main components of metabolic syndrome: waist circumference, triglycerides, high-density lipoproteins ( HDL) cholesterol, blood pressure, and fasting glucose. These components are central to the definition of metabolic syndrome and are commonly used to assess the efficacy of interventions. The Composite Metabolic Syndrome Score combines multiple metabolic risk factors and typically ranges from 0 (optimal) to 5 (worst), with higher scores indicating a worse outcome.
次要结局
- Waist Circumference change in cm(6 months)
- HDL Cholesterol change in mg/dl(6 months)
- Blood Pressure change in mmHg(6 months)
- body mass index (BMI) change(6 months)
- Triglycerides change in mg/dl(6 months)
- High-Sensitivity C-Reactive Protein change(6 months)
- Body Weight change in kg(6 months)
- Fasting Glucose in mg/dl(6 months)
- Incidence of any Adverse Effects(6 months)