The Nutrition Researcher Cohort 2014 Study



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2015
End Date:January 2025
Contact:Ivana Bobeldijk, PhD
Email:ivana.bobeldijk@tno.nl
Phone:+31 888 66 16 25

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The Nutrition Researcher Cohort 2014 Study; New Standardized Self-quantification Methodologies Serving Both Research and Personal Health Maintenance

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).

Inclusion Criteria:

- 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.

Exclusion Criteria:
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30 Lower Campus Road
Medford, Massachusetts 02155
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