The Nutrition Researcher Cohort 2014 Study; New Standardized Self-quantification Methodologies Serving Both Research and Personal Health Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
- 试验地点
- 12
- 主要终点
- Blood pressure
研究概览
简要总结
The primary objective of the planned Nutrition Research Cohort (NRC) n250 study is to develop and evaluate the open access Nutrition Researcher Cohort for gathering personal health data from nutrition researchers, including analytical methods, standards and operation procedures, data infrastructure, ethical and privacy aspects, and governance.
Besides, the study aims to exploit and analyse data on food, nutrient and bioactive compound intake and exposure, biomarkers for food, health and/or disease and health and/or disease related measurements to study the relation between nutrition, health and development of disease (on individual level).
In addition, data will be used to develop applications that visualise personal health risks based for example on (validated) recommendations and applications that predict individual health risks.
The study is designed as an open, one-group, exploratory cohort study. The total NRC cohort will be composed of about 250 life sciences employees and students from different, predominantly European, countries. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about in total 20 male and female scientists per participating country.
详细描述
The NRC n250 study is an open, one-group, open-ended cohort study, which will include participants from 10 different countries. The study will be coordinated by national contact points from each of the participating countries.
The NRC cohort study will start early 2015 and continue developing from that moment on. Recruitment will start immediately after approval of the study protocol in the country where it has been submitted. The Participant Information Form, which contains the complete research protocol as developed by the consortium partners, is available online via the NRC website. This way, potential participants can make an informed decision on whether or not they want to participate.
The NRC n250 study will provide a dataset from 250 individuals, including food intake, microbiome composition, oral glucose tolerance tests, a series of plasma (bio)chemistry outcomes, plasma and urine metabolome and DNA damage, together with anthropometrics and life style questionnaires.
Since the aim is to build up a powerful open access cohort, there is no end-date defined for this study. The collected data will be used for various analyses on food intake, biomarkers for food intake and/or health and/or disease, and health/disease related measurements.
The research questions that will be answered with this cohort are largely not known yet, since it is not known which data will become available. A NRC Scientific committee is established to judge whether or not the data in the cohort may be used for answering the proposed research questions. This Scientific committee consists of the principal investigators of the individual participating countries.
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
- •Employees or students that are active in the field of nutrition and/or biology and/or health (e.g. epidemiologists, dieticians, nutrition students and researchers) that have a basic knowledge of nutrition and/or human biology and are thus able to form a scientific judgement on his/her own health data;
- •good understanding of the English written language, since all communication is handled in English.
排除标准
- 未提供
结局指标
主要结局
Blood pressure
时间窗: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
Diastolic and systolic blood pressure; measured with do-it-yourself device in at-home setting
Body height
时间窗: Baseline (week 1)
measured with do-it-yourself device in at-home setting
Body weight
时间窗: Each week during entire cohort (five years in total)
measured with do-it-yourself device in at-home setting
Single Nucleotide Polymorphism (SNP) profile
时间窗: Once during the cohort at baseline (a timepoint chosen by the participant in the first three months of the cohort)
No specific time of measurement has to be specified as genetic profile is not subject to change
Waist-to-hip ratio
时间窗: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
measured with waist circumference and hip circumference; measured with centimeter in at-home setting
fasting blood glucose
时间窗: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
measured after 8h fasting (only drinking water is allowed); measured with do-it-yourself device in at-home setting
Blood cholesterol
时间窗: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
HDL, LDL, total cholesterol, triglycerides; measured with do-it-yourself device in at-home setting
Resting heart rate
时间窗: Monthly during entire cohort (Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 for each year of the five year cohort)
measured after sitting still for at least 5 minutes; measured with do-it-yourself device in at-home setting
Food intake
时间窗: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
registration of food intake during two weekdays and one weekend day via an online application (e.g. FatSecret)
Physical activity tracker
时间窗: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Registration of physical activity with a physical activity tracker (e.g. FitBit) for at least one week continuously
次要结局
- biomarker profile(once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available)
- metagenome(once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available)
- metabolomics(once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available)
- lifestyle (smoking, alcohol consumption, etc.)(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- stress questionnaire(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- general food intake(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- cognition(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- quality of life(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- do-it-yourself oral glucose tolerance test(once, at baseline (at a timepoint chosen by the participant in the first three months of the cohort); this measure will be repeated only if funding for analysis becomes available)
- general health status(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- quality of sleep(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- physical activity(once per year during entire cohort (Month 12, M24, M36, M48, M60))
- wellness(once per year during entire cohort (Month 12, M24, M36, M48, M60))
研究者
Ivana Bobeldijk-Pastorova
Project Manager
TNO