Personalized Responses to Dietary Composition Trial 3
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250,000
- 试验地点
- 3
- 主要终点
- Gut microbiome species richness
研究概览
简要总结
The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.
详细描述
Choice of design: The study is a single arm mechanistic intervention study.
Study population: The subject must have enrolled in the commercial ZOE testing program in order to apply for participation in the PREDICT 3 research program.
Screening Assessment: The study eligibility criteria listed below closely match to the commercial eligibility criteria, which ZOE users consent to before enrolling in the commercial program.
Study duration: Each participant will take part in the study for 6-14 days.
Dietary intervention: The dietary intervention will be carried out on up to 6 days with the option to continue monitoring for a total study period of 14-days. On day one, participants will be asked to fit glucose monitor. Over the following consecutive days, each participant will be instructed to eat 2 standardized meals. Participants are free to eat whatever they wish at all other times. The standardized meals will be provided to all participants by the study team via post. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in US supermarkets. Participants will be asked to consume the entire amount of food indicated for the standardized meals and to record any left-over food via a digital app for which training will be provided at the start of the study. Following completion of standardized meal period, participants are free to eat and drink whatever they wish and will be asked to track all meals, snacks and drinks on their digital app. Participants will also be advised not to change their physical activity patterns during the course of the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in the commercial ZOE testing program
- •Minimum 18 years of age (minimum 19 years of age in Alabama and Nebraska due to state laws)
- •Body mass index (BMI) of greater than or equal to 16.5 kg/m
- •Living in the continental US states, other than in New York (excluded from the ZOE testing product also as they are unable to access the dried blood spot service provided by Quest), or living in the UK
- •Able and willing to comply with the study protocol and provide informed consent.
- •Under care for chronic medical conditions (including eating disorders, type 1 diabetes, type 2 diabetes), and confirm they have checked with their primary care physician that this study is safe for them (US cohort only)
排除标准
- •Cannot safely eat the pre-made test meals which contain standard US ingredients, e.g. due to allergy or recent gastrointestinal surgery, or are unwilling to consume these foods.
- •Are pregnant.
- •Have had a heart attack (myocardial infarction), stroke/transient ischemic attack (TIA), or major surgery in the last two months.
- •Are unable to read and write in English, as the ZOE app is only available in English.
结局指标
主要结局
Gut microbiome species richness
时间窗: 1 day
Species count in fecal sample (as part of ZOE testing program)
Blood Lipids
时间窗: 1 day
Measurement of baseline and 6-h post-prandial triglycerides (mmol/L) by dried blood sample (as part of ZOE testing program)
Hunger and appetite assessment
时间窗: 6-14 days
Self-reported in-app question on energy levels (categorical) (as part of ZOE testing program)
Glucose and HbA1c
时间窗: 2 days
Measurement of baseline glucose (mmol/L) and HbA1c (%) by dried blood sample (as part of ZOE testing program)
Glucose
时间窗: 6-14 days
Measurement of blood glucose by continuous glucose monitor (mmol/L)
次要结局
- Perceived Energy Assessment(6-14 days)
- Covid-19 symptom assessment(6 months)
- Dietary assessment(1 month)
- Bowel Type and Habit(6-14 days)
- Anthropometry(1 day)