The Nutrition Researcher Cohort 2014 Study

NCT ID: NCT02522390

Last Updated: 2017-04-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Nutritional Physiological Phenomena Health Biological Markers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Do-it-yourself devices filling out online-questionnaires sample collection with supplied kits

Eligibility Criteria

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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

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

NIHS

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role collaborator

Newcastle University

OTHER

Sponsor Role collaborator

Technical University Munchen

UNKNOWN

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

University of Graz

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role collaborator

Charles University, Czech Republic

OTHER

Sponsor Role collaborator

NuGo

UNKNOWN

Sponsor Role collaborator

VITAS Analytical Services

UNKNOWN

Sponsor Role collaborator

Humboldt-Universität zu Berlin

OTHER

Sponsor Role collaborator

CSIRO Animal, Food and Health Sciences

UNKNOWN

Sponsor Role collaborator

SwissAnalysis AG

UNKNOWN

Sponsor Role collaborator

Agroscope Liebefeld-Posieux Research Station ALP

OTHER

Sponsor Role collaborator

CRA NUT - Centro di Ricerca per gli Alimenti e la Nutrizione

UNKNOWN

Sponsor Role collaborator

TNO

OTHER

Sponsor Role lead

Responsible Party

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Ivana Bobeldijk-Pastorova

Project Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

University of Leuven (KU Leuven)

Leuven, , Belgium

Site Status

Charles University Prague

Prague, , Czechia

Site Status

University of Copenhagen

Copenhagen, , Denmark

Site Status

University of Eastern Finland

Kuopio, , Finland

Site Status

INRA - L'Institut Nationel de la Recherche Agronomique

Clermont, , France

Site Status

University College Dublin

Dublin, , Ireland

Site Status

CRA-NUT - Centro di Ricerca per gli Alimenti e la Nutrizione

Rome, , Italy

Site Status

TNO

Zeist, Gelderland, Netherlands

Site Status

University of Barcelona

Barcelona, , Spain

Site Status

Agroscope, Institute for Food Sciences

Bern, , Switzerland

Site Status

Newcastle University

Newcastle, , United Kingdom

Site Status

Countries

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Austria Belgium Czechia Denmark Finland France Ireland Italy Netherlands Spain Switzerland United Kingdom

Other Identifiers

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P9616

Identifier Type: -

Identifier Source: org_study_id

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