NCT02945514已完成不适用
Validation of the Measurement and Prediction of the Postprandial Glycemic Response to Food and Providing Personally Tailored Dietary Recommendations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Postprandial blood sugar level
研究概览
简要总结
Provide personally tailored dietary suggestions to participants based on the Personalized Prediction Engine (patent pending) owned by DayTwo.
详细描述
- Answer personal questions including such things as health information, eating habits and preferences, activity level and intensity.
- Submit a first stool sample via a self-addressed, postage-paid kit that is mailed to you.
- Attend one of the 2 hour connection meetings based on available dates.
- The study team will collect vitals: measurements of height, weight, blood pressure, pulse, waist and hip circumference.
- You will have a Blood collection for study (approximately 35 ml of blood/5 tubes)
- You will be provided a FitBit wrist band that you will wear
- You will be provided a manual blood glucose monitor you will use for pricking finger and measuring blood sugar level at least 4 times per day.
- You will have a continuous blood glucose sensor and monitor inserted by study staff.
- You will use DayTwo's mobile application where you will input food eaten, activity, measurements, medications, and sleep.
- You will be given a second stool kit and instructions for collection.
- You will be asked to eat 4 breakfasts consisting of either bagels and cream cheese or cereal. These foods will be provided for you. Other than these four breakfasts, we would like you to follow your normal eating habits during the collection week.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Comprehension of the study objectives and requirements
- •Ability to download the DayTwo proprietary mobile application
- •Ability to access the DayTwo website for registration and nutrition report
排除标准
- •Under 18 years of age
- •Pre-diagnosed type I or type II diabetes mellitus
- •Pregnancy
- •Use of antibiotics or fertility treatments within 3 months prior to participation
- •Bariatric weight loss surgery
- •Chronic Anemia (hemoglobin of 10g per deciliter or less
- •Chronic gastrointestinal disorder (IBD, Celiac, etc.)
- •Active cancer or chemotherapy or radiation within 2 years prior to participation
- •Condition not allowing to follow the dietary recommendation during the study
- •4 or more alcoholic drinks per day on a regular basis or use of recreational drugs
- •Chronic medical condition, treatment, or medication that may affect glucose metabolism (HIV diagnosis, use of steroids or immunosuppressive drugs, etc.)
结局指标
主要结局
Postprandial blood sugar level
时间窗: Baseline through 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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