Clinical trial NCT02522390: The Nutrition Researcher Cohort 2014 Study
Official title: The Nutrition Researcher Cohort 2014 Study; New Standardized Self-quantification Methodologies Serving Both Research and Personal Health Maintenance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutritional Physiological Phenomena
Health
Biological Markers
Keywords: data collection
personal health services
personal health records
do-it-yourself
nutrition researchers
cohort studies
databases, factual
self-quantification methods
Lead sponsor: TNO
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
name: Lund University
name: NIHS
name: University of Barcelona
name: University College Dublin
name: Newcastle University
name: Technical University Munchen
name: Universitaire Ziekenhuizen KU Leuven
name: University of Oslo
name: University of Copenhagen
name: University of Graz
name: Tufts University
name: Charles University, Czech Republic
name: NuGo
name: VITAS Analytical Services
name: Humboldt-Universität zu Berlin
name: CSIRO Animal, Food and Health Sciences
name: SwissAnalysis AG
name: Agroscope Liebefeld-Posieux Research Station ALP
name: CRA NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
First posted: 2015-08-13
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Body height
timeFrame: Baseline (week 1)
measure: Body weight
timeFrame: Each week during entire cohort (five years in total)
measure: Single Nucleotide Polymorphism (SNP) profile
timeFrame: Once during the cohort at baseline (a timepoint chosen by the participant in the first three months of the cohort)
measure: Waist-to-hip ratio
timeFrame: 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)
measure: Blood pressure
timeFrame: 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)
measure: Resting heart rate
timeFrame: 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)
measure: fasting blood glucose
timeFrame: 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)
measure: Blood cholesterol
timeFrame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
measure: Food intake
timeFrame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
measure: Physical activity tracker
timeFrame: quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Secondary outcomes:
measure: biomarker profile
timeFrame: 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
measure: do-it-yourself oral glucose tolerance test
timeFrame: 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
measure: metabolomics
timeFrame: 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
measure: metagenome
timeFrame: 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
measure: general health status
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: lifestyle (smoking, alcohol consumption, etc.)
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: general food intake
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: quality of sleep
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: stress questionnaire
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: physical activity
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: wellness
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: cognition
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
measure: quality of life
timeFrame: once per year during entire cohort (Month 12, M24, M36, M48, M60)
Other outcomes:
measure: compliance with the study protocol
timeFrame: after one year (june 2016)
measure: user experiences with participating in the cohort
timeFrame: after one year (june 2016)
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Leuven
country: Belgium
facility: University of Leuven (KU Leuven)
city: Prague
country: Czechia
facility: Charles University Prague
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Kuopio
country: Finland
facility: University of Eastern Finland
city: Clermont
country: France
facility: INRA - L'Institut Nationel de la Recherche Agronomique
city: Dublin
country: Ireland
facility: University College Dublin
city: Rome
country: Italy
facility: CRA-NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
city: Zeist
country: Netherlands
facility: TNO
state: Gelderland
city: Barcelona
country: Spain
facility: University of Barcelona
city: Berne
country: Switzerland
facility: Agroscope, Institute for Food Sciences
city: Newcastle
country: United Kingdom
facility: Newcastle University
Study officials:
affiliation: TNO
name: André Boorsma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle University
name: Baukje de Roos
role: PRINCIPAL_INVESTIGATOR
affiliation: CRA-NUT
name: Giuditta Perozzi
role: PRINCIPAL_INVESTIGATOR
affiliation: University College Dublin
name: Lorraine Brennan
role: PRINCIPAL_INVESTIGATOR
affiliation: University Leuven
name: Christophe Matthys
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Irina Dobre
role: PRINCIPAL_INVESTIGATOR
affiliation: Charles University Prague
name: Miroslav Petr
role: PRINCIPAL_INVESTIGATOR
affiliation: INRA - French National Institute for Agricultural Research
name: Andre Mazur
role: PRINCIPAL_INVESTIGATOR
affiliation: Agroscope Liebefeld-Posieux Research Station ALP
name: Guy Vergères, PhD Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Eastern Finland
name: Marjukka Kolehmainen
role: PRINCIPAL_INVESTIGATOR
affiliation: Med Uni Graz
name: Sandra Wallner
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Cristina Andres-Lacueva
role: PRINCIPAL_INVESTIGATOR
References: