Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
192 participants
OBSERVATIONAL
2015-01-31
2025-01-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nutrition Researcher Cohort
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* good understanding of the English written language, since all communication is handled in English.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of Eastern Finland
OTHER
Lund University
OTHER
NIHS
UNKNOWN
University of Barcelona
OTHER
University College Dublin
OTHER
Newcastle University
OTHER
Technical University Munchen
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
University of Oslo
OTHER
University of Copenhagen
OTHER
University of Graz
OTHER
Tufts University
OTHER
Charles University, Czech Republic
OTHER
NuGo
UNKNOWN
VITAS Analytical Services
UNKNOWN
Humboldt-Universität zu Berlin
OTHER
CSIRO Animal, Food and Health Sciences
UNKNOWN
SwissAnalysis AG
UNKNOWN
Agroscope Liebefeld-Posieux Research Station ALP
OTHER
CRA NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
UNKNOWN
TNO
OTHER
Responsible Party
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Ivana Bobeldijk-Pastorova
Project Manager
Principal Investigators
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André Boorsma, PhD
Role: PRINCIPAL_INVESTIGATOR
TNO
Baukje de Roos
Role: PRINCIPAL_INVESTIGATOR
Newcastle University
Giuditta Perozzi
Role: PRINCIPAL_INVESTIGATOR
CRA-NUT
Lorraine Brennan
Role: PRINCIPAL_INVESTIGATOR
University College Dublin
Christophe Matthys
Role: PRINCIPAL_INVESTIGATOR
University Leuven
Irina Dobre
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Miroslav Petr
Role: PRINCIPAL_INVESTIGATOR
Charles University Prague
Andre Mazur
Role: PRINCIPAL_INVESTIGATOR
INRA - French National Institute for Agricultural Research
Guy Vergères, PhD Dr
Role: PRINCIPAL_INVESTIGATOR
Agroscope Liebefeld-Posieux Research Station ALP
Marjukka Kolehmainen
Role: PRINCIPAL_INVESTIGATOR
University of Eastern Finland
Sandra Wallner
Role: PRINCIPAL_INVESTIGATOR
Med Uni Graz
Cristina Andres-Lacueva
Role: PRINCIPAL_INVESTIGATOR
University of Barcelona
Locations
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Medizinische Universität Graz
Graz, , Austria
University of Leuven (KU Leuven)
Leuven, , Belgium
Charles University Prague
Prague, , Czechia
University of Copenhagen
Copenhagen, , Denmark
University of Eastern Finland
Kuopio, , Finland
INRA - L'Institut Nationel de la Recherche Agronomique
Clermont, , France
University College Dublin
Dublin, , Ireland
CRA-NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
Rome, , Italy
TNO
Zeist, Gelderland, Netherlands
University of Barcelona
Barcelona, , Spain
Agroscope, Institute for Food Sciences
Bern, , Switzerland
Newcastle University
Newcastle, , United Kingdom
Countries
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Other Identifiers
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P9616
Identifier Type: -
Identifier Source: org_study_id
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