An observational study in Nutritional Physiological Phenomena, Health and Biological Markers, sponsored by TNO. Status unknown at 12 sites in 12 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-26.
Sponsored by TNO · Observational
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.
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.
The Scientific committee is the entity that views all proposals (new studies, research questions) and decides whether or not it is in line with aim of NRC as well as ethics as well as scientifically robust. Approval for proposals can be obtained by positive response from a majority of the members (quality and ethics of proposals).
Institutions/companies that obtain data for a specific proposal, are only allowed to use the data for that specific purpose.
The NRC cohort also aims to serve as a platform to validate specific questionnaires (including food intake) or additional measurements (that are within scope of the NRC objectives). For offering an additional measurement or questionnaire to participants for health parameters that are already included in the protocols, also a request for approval should be filed to the scientific committee. The scientific committee will then decide (based on a positive response of the majority of the committee) if this measurement or questionnaire may be added. A request for data analysis with these new measures or questionnaires, other than validation purposes, has to be filed separately. If a request for approval is granted, participants still have the opportunity to opt out their data for use for this purpose.
For research questions that require additional measurements for health parameters that are not yet included in the protocol, amendments will be submitted to the Dutch Medical Research and Ethics Committee (MREC).
The NRC cohort will be composed of employees and students in the area of life sciences. This allows optimal involvement of participants in shaping all aspects of the cohort and the ownership of data. We aim to recruit about 250 male and female scientists for the entire cohort. For each participating country it is aimed to recruit about 25 participants, taking drop-out and varying submission and/or starting dates between the 15 participating countries into account. Besides, a higher number of participants will increase the chance of being able to compare the data with other countries.
Exclusion Criteria:
This cohort study is an observational, one-group study. The intervention consists of research activities that participants are asked to perform throughout the cohort, including the use of do-it-yourself devices, filling out online-questionnaires and sample collection with supplied kits for the analysis of various health parameters. The frequency with which participants are asked to measure these health parameters varies, ranging from once to weekly.
Other: Research activities
Measurements are primarily based on "do-it-yourself" non-invasive or minimally invasive methods. Participants upload collected data to the Personal Health Portal. The measurements are divided into required and optional measurements. The required measurements mainly include routine methodology (e.g. weight, blood pressure, blood glucose); the latter also include methods under development that will be fine-tuned along the project. Which additional measures will be offered to participants is dependent on if funding or in-kind sponsoring is available. Participants will receive measurement kits for these analyses at-home and will be responsible for collection, labeling and shipment of samples themselves. After analysis the resulting data are uploaded to the user accounts.
Also known as: Do-it-yourself devices, filling out online-questionnaires, sample collection with supplied kits
Body height
measured with do-it-yourself device in at-home setting
Time frame: Baseline (week 1)
Body weight
measured with do-it-yourself device in at-home setting
Time frame: Each week during entire cohort (five years in total)
Single Nucleotide Polymorphism (SNP) profile
No specific time of measurement has to be specified as genetic profile is not subject to change
Time frame: Once during the cohort at baseline (a timepoint chosen by the participant in the first three months of the cohort)
Waist-to-hip ratio
measured with waist circumference and hip circumference; measured with centimeter in at-home setting
Time frame: 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)
Blood pressure
Diastolic and systolic blood pressure; measured with do-it-yourself device in at-home setting
Time frame: 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)
Resting heart rate
measured after sitting still for at least 5 minutes; measured with do-it-yourself device in at-home setting
Time frame: 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)
fasting blood glucose
measured after 8h fasting (only drinking water is allowed); measured with do-it-yourself device in at-home setting
Time frame: 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)
Blood cholesterol
HDL, LDL, total cholesterol, triglycerides; measured with do-it-yourself device in at-home setting
Time frame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Food intake
registration of food intake during two weekdays and one weekend day via an online application (e.g. FatSecret)
Time frame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Physical activity tracker
Registration of physical activity with a physical activity tracker (e.g. FitBit) for at least one week continuously
Time frame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
biomarker profile
biomarkers for food intake (vitamins, fatty acids) and other blood biomarkers (cortisol, C Reactive protein (CRP), thyroid stimulating hormone (TSH), etc.)
Time frame: 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
do-it-yourself oral glucose tolerance test
insulin, glucose, c-peptide, HbA1c; including response profile after oral glucose tolerance test
Time frame: 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
Time frame: 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
Time frame: 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
via a questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
lifestyle (smoking, alcohol consumption, etc.)
via a questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
general food intake
via a food frequency questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of sleep
via a questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
stress questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
physical activity
via a questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
wellness
via a questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
cognition
via a questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of life
via a questionnaire
Time frame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
compliance with the study protocol
compliance will be determined for each of the included measurements and compared between participating countries
Time frame: after one year (june 2016)
user experiences with participating in the cohort
as measured via a questionnaire
Time frame: after one year (june 2016)
Plan to share: Yes — An internal review board, consisting of Principal Investigators from all participating countries, will review all data requests. A data request format is available that should be used for filing such a request. The format requires stating the research questions that should be answered with the requested data, type of data, populations requirements (exclusion criteria), data analysis and public disclosure. All study participants have the ability to withdraw their data from use for answering specific research questions at any time.
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