The main goal of the NRC in the planned 2014 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…
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Brief title
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Synonym
Health condition
algemeen gezondheidsparameters, biomarkers en voeding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The open access Nutrition Researcher Cohort for gathering personal health data
from nutrition researchers will be evaluated by determining compliance of
participants with the research protocol. Compliance will be determined for
self-quantification methods that all participants are expected to use, as well
as the optional measures. Compliance of participants with the study protocol
will also be compared between countries.
User experiences with participating in the cohort and using
self-quantification methods for monitoring their health will be assessed with a
questionnaire on user-experience after one year. This questionnaire has not yet
been finalized, as it is not yet clear which specific self-quantification
methods will be included in the cohort. However, a format for this
questionnaire has already been developed (F09). The questionnaire will
encompass questions on the cohort in general, the used visualisations for
personal data, usability of the self-quantification methods, the satisfaction
of the user with the self-quantification methods and the effects of
self-quantification on user behaviour.
Secondary outcome
Dependent on the quality, the data resulting from the self-quantification
methods (including body weight, physical activity, food intake, blood glucose,
blood pressure, resting heart rate, quality of sleep, cortisol in hair,
epigenetics, etc.) will be analysed to identify changes in these health
parameters over time.
These self-quantification methods can be divided into two groups, namely the
self-quantification methods that are mandatory for all participants and those
that are optional. The first group of self-quantification methods include
conventional non-invasive or minimally invasive measures, like body weight,
waist circumference, blood pressure, fasting glucose and blood lipids with
finger prick. The set of optional self-quantification methods, which are more
complex or invasive methods, is not yet set. Which measurements will be offered
to participants is dependent on funding. Examples of measurements that could be
included are concentrations of biomarkers in blood, cortisol in hair/nail (as a
biomarker for stress) clippings and epigenetic profile.
The complete lists of mandatory and optional self-quantification measurements
and the can be found in table 1-2, respectively table 3. Table 1 and 2 also
contain the procedures that participants should use for each of the included
measurements. Table 3 contains the required laboratory analysis methods and the
intended labs.
All subjects will also be asked to regularly fill out online-questionnaires on
general health status, lifestyle (smoking, alcohol consumption), quality of
sleep, stress, physical activity and quality of life (table 2). Which specific
questionnaires will be used in this cohort, has not yet been decided on.
However, sample questionnaires have been added to this protocol as an
indication for the expected burden for participants (chapter 11).
Background summary
Healthy nutrition has large potential in reducing risks of diseases like cancer
and cardiovascular disease. However, the population-based approaches via which
healthy nutrition is stimulated have been largely ineffective. In the past
decade, new developments in the application of advanced nutrigenetics
technologies, and bioinformatics providing integration of relevant data, have
furthered the concept of personalized nutrition, causing a paradigm shift from
the mindset of *one-diet-fits-all* to *the right diet for the right person at
the right time*. Personalized nutrition could address the current limitations
and transform the nutrition research field. The ultimate goal of personalized
nutrition is that in the future, each individual is empowered to make personal
and sustainable choices on diet that optimally fit her/his health maintenance
and lifestyle. This includes access to reliable information on personal health
trajectory and status, and the effect of diet(ary changes) on personal health.
The Nutrition Researcher Cohort (NRC) aims to build such a *personal health
portal* that allows use of anonymized data for research, but also provides all
participants with their personal health data as well as dietary advice with
personal dietary advice systems based on the individual`s health trajectory. As
a basis for this NRC, it is aimed to establish and optimize new standardized
methodology of self-quantification serving both research and (personal) health
maintenance/optimization.
Study objective
The main goal of the NRC in the planned 2014 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. This will be measured by compliance of participants with the
research protocol, and user experiences concerning participation in the cohort
and use of self-quantification methods.
The specific objectives of the NRC in the 2014 study are:
1. To gather data, that is collected by study participants with
self-quantification methods, that:
• give an accurate estimate of food intake and exposure to diets and dietary
bioactives
• represent robustly measured biomarkers for health and (emerging) risk factors
for disease
2. To exploit and analyse data on
• food, nutrient and bioactive compound intake and exposure
• biomarkers for food intake and/or health and/or disease
• health and/or diseases related measurements
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. For research purposes the data will be
used for collaboration research as well as comparisons.
Study design
The NRC 2014 study is an open, one-group, open-ended cohort study. The NRC
cohort 2014 study has already started in Finland. The NRC cohort study in the
Netherlands will preferably start in 2014 and continue developing from that
moment on. Recruitment will thus start immediately after approval of the study
protocol. 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 2014 study will provide a dataset of 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. However, after one year the NRC cohort will be
evaluated. The evaluation of the study concerns the compliance of the subjects
with the provided research protocol, as well as their experiences with
participating in the cohort. Besides, the collected data will be used for
various (descriptive) analyses on food intake, biomarkers for food intake
and/or health and/or disease, and health/disease related measurements.
Study burden and risks
Data collection will be primarily based on *do-it-yourself* non-invasive or
minimally invasive methods. These data will be delivered by the participant to
the Personal Health Portal. For some health parameters, participants will send
their samples to labs for analysis; in this case, the lab will be responsible
for uploading the data to the portal. For each health parameter the participant
can decide whether or not these data can also be used for research purposes. We
do not foresee any health risks in using the do-it-yourself methods for
measuring health parameters. All methods have been used in previous studies and
most are commercially available, and are therefore, with normal use, considered
safe. Data of the study will be uploaded to the online NRC portal by an account
created by the study-participant. Personal data and research data are stored in
separate databases. Research data is stored pseudonymized, such that
researchers that analyse the data cannot connect data to an individual.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
1. 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;
2. good understanding of the English written language, since all communication is handled in English.
Exclusion criteria
For any participant who matches the inclusion criteria, there are no exclusion criteria. The concept of the Nutrition Researcher Cohort is that research is performed on a *multiple N=1* basis, i.e. each participant provides his/her own health dataset and as such a wide range of healthy and possibly unhealthy subjects can participate. ;In the future, for the proposed research questions suggested by the participants of NRC and agreed in the management of the NRC, a selection may be made including/excluding part of the phenotypes.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52069.028.15 |