Personalized Nutrition Prediction for Metabolic Syndrome Patients, an Open Single-center Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- To determine number of participants with reduced BMI
研究概览
简要总结
This clinical study is designed to evaluate the providing of a computational prediction engine for optimization of personalized nutrition
Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.
详细描述
Pre-diabetic and pre-metabolic syndrome patients will be recruited to the study for a period of one year.
After measurement of individual's parameters changes as blood tests, gut microbiome, urine tests, blood pressure, heart performance, body circumferences, mood and mental status as well as monitoring each individual's food intake - a model to predict individual's body reaction according to lifestyle, eating and activity habits will be built.
Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions will be provided on a bi-weekly basis, all Lab tests and dietician control will be performed twice a month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Adults age 18-65
- •HBA1C between 5.5 and 7%.
- •Altered lipid metabolism
- •Signed Informed Consent
排除标准
- •Usage of antibiotics within three months prior to participation
- •Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
- •Chronic gastrointestinal disorder, including Inflammatory Bowel Disease and Celiac Disease
- •Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor
- •Active psychiatric disorder
- •Myocardial infarction or cerebrovascular accident in the 6 months prior to participation
- •Chronic immunosuppressive medication usage
- •Clinical depression
结局指标
主要结局
To determine number of participants with reduced BMI
时间窗: One year
Change at 12 months
To determine number of participants with reduced hA1C
时间窗: One year
Change at 12 months
To determine number of participants with reduced cholesterol
时间窗: One year
Change at 12 months
次要结局
- Type of intestinal microorganisms(One year)
- Number of intestinal microorganisms(One year)