The Nutrition Researcher Cohort 2014 Study
- Conditions
- Nutritional Physiological PhenomenaHealthBiological Markers
- Interventions
- Other: Research activities
- Registration Number
- NCT02522390
- Lead Sponsor
- TNO
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 192
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Nutrition Researcher Cohort Research activities 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.
- Primary Outcome Measures
Name Time Method Body height Baseline (week 1) measured with do-it-yourself device in at-home setting
Body weight Each week during entire cohort (five years in total) measured with do-it-yourself device in at-home setting
Blood pressure 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) Diastolic and systolic blood pressure; measured with do-it-yourself device in at-home setting
Single Nucleotide Polymorphism (SNP) profile Once during the cohort at baseline (a timepoint chosen by the participant in the first three months of the cohort) No specific time of measurement has to be specified as genetic profile is not subject to change
Waist-to-hip ratio 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) measured with waist circumference and hip circumference; measured with centimeter in at-home setting
fasting blood glucose 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) measured after 8h fasting (only drinking water is allowed); measured with do-it-yourself device in at-home setting
Blood cholesterol quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort) HDL, LDL, total cholesterol, triglycerides; measured with do-it-yourself device in at-home setting
Resting heart rate 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) measured after sitting still for at least 5 minutes; measured with do-it-yourself device in at-home setting
Food intake quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort) registration of food intake during two weekdays and one weekend day via an online application (e.g. FatSecret)
Physical activity tracker quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort) Registration of physical activity with a physical activity tracker (e.g. FitBit) for at least one week continuously
- Secondary Outcome Measures
Name Time Method wellness once per year during entire cohort (Month 12, M24, M36, M48, M60) via a questionnaire
biomarker profile 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 biomarkers for food intake (vitamins, fatty acids) and other blood biomarkers (cortisol, C Reactive protein (CRP), thyroid stimulating hormone (TSH), etc.)
metagenome 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 metabolomics 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 lifestyle (smoking, alcohol consumption, etc.) once per year during entire cohort (Month 12, M24, M36, M48, M60) via a questionnaire
stress questionnaire once per year during entire cohort (Month 12, M24, M36, M48, M60) general food intake once per year during entire cohort (Month 12, M24, M36, M48, M60) via a food frequency questionnaire
physical activity once per year during entire cohort (Month 12, M24, M36, M48, M60) via a questionnaire
cognition once per year during entire cohort (Month 12, M24, M36, M48, M60) via a questionnaire
quality of life once per year during entire cohort (Month 12, M24, M36, M48, M60) via a questionnaire
do-it-yourself oral glucose tolerance test 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 insulin, glucose, c-peptide, HbA1c; including response profile after oral glucose tolerance test
general health status once per year during entire cohort (Month 12, M24, M36, M48, M60) via a questionnaire
quality of sleep once per year during entire cohort (Month 12, M24, M36, M48, M60) via a questionnaire
Trial Locations
- Locations (12)
University College Dublin
🇮🇪Dublin, Ireland
Agroscope, Institute for Food Sciences
🇨ðŸ‡Berne, Switzerland
TNO
🇳🇱Zeist, Gelderland, Netherlands
Charles University Prague
🇨🇿Prague, Czechia
University of Leuven (KU Leuven)
🇧🇪Leuven, Belgium
INRA - L'Institut Nationel de la Recherche Agronomique
🇫🇷Clermont, France
CRA-NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
🇮🇹Rome, Italy
Medizinische Universität Graz
🇦🇹Graz, Austria
University of Copenhagen
🇩🇰Copenhagen, Denmark
University of Eastern Finland
🇫🇮Kuopio, Finland
University of Barcelona
🇪🇸Barcelona, Spain
Newcastle University
🇬🇧Newcastle, United Kingdom