The Nutrition Researcher Cohort 2014 Study (NRC250)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Biological Markers; Health; Nutritional Physiological Phenomena
• Intervention / Treatment: Other: Research activities

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).

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Medizinische Universität Graz
• Belgium
  • Leuven, Belgium
    • University of Leuven (KU Leuven)
• Czechia
  • Prague, Czechia
    • Charles University Prague
• Denmark
  • Copenhagen, Denmark
    • University of Copenhagen
• Finland
  • Kuopio, Finland, FI-70210
    • University of Eastern Finland
• France
  • Clermont, France
    • INRA - L'Institut Nationel de la Recherche Agronomique
• Ireland
  • Dublin, Ireland
    • University College Dublin
• Italy
  • Rome, Italy, 00178
    • CRA-NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
• Netherlands
  • Gelderland
    • Zeist, Gelderland, Netherlands
      • TNO
• Spain
  • Barcelona, Spain
    • University of Barcelona
• Switzerland
  • Berne, Switzerland
    • Agroscope, Institute for Food Sciences
• United Kingdom
  • Newcastle, United Kingdom
    • Newcastle University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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 Names: Do-it-yourself devices; filling out online-questionnaires; sample collection with supplied kits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body height	measured with do-it-yourself device in at-home setting	Baseline (week 1)
Body weight	measured with do-it-yourself device in at-home setting	Each week during entire cohort (five years in total)
Single Nucleotide Polymorphism (SNP) profile	No specific time of measurement has to be specified as genetic profile is not subject to change	Once during the cohort at baseline (a timepoint chosen by the participant in the first three months of the cohort)
Waist-to-hip ratio	measured with waist circumference and hip circumference; measured with centimeter in at-home setting	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)
Blood pressure	Diastolic and systolic blood pressure; measured with do-it-yourself device in at-home setting	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)
Resting heart rate	measured after sitting still for at least 5 minutes; measured with do-it-yourself device in at-home setting	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)
fasting blood glucose	measured after 8h fasting (only drinking water is allowed); measured with do-it-yourself device in at-home setting	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)
Blood cholesterol	HDL, LDL, total cholesterol, triglycerides; measured with do-it-yourself device in at-home setting	quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Food intake	registration of food intake during two weekdays and one weekend day via an online application (e.g. FatSecret)	quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)
Physical activity tracker	Registration of physical activity with a physical activity tracker (e.g. FitBit) for at least one week continuously	quarterly during entire cohort (Month 3, M6, M9, M12 for each year of the five year cohort)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biomarker profile	biomarkers for food intake (vitamins, fatty acids) and other blood biomarkers (cortisol, C Reactive protein (CRP), thyroid stimulating hormone (TSH), etc.)	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
do-it-yourself oral glucose tolerance test	insulin, glucose, c-peptide, HbA1c; including response profile after 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
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
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
general health status	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
lifestyle (smoking, alcohol consumption, etc.)	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
general food intake	via a food frequency questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of sleep	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
stress questionnaire		once per year during entire cohort (Month 12, M24, M36, M48, M60)
physical activity	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
wellness	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
cognition	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
quality of life	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance with the study protocol	compliance will be determined for each of the included measurements and compared between participating countries	after one year (june 2016)
user experiences with participating in the cohort	as measured via a questionnaire	after one year (june 2016)

Collaborators and Investigators

• Sponsor: TNO
• Collaborators: Charles University, Czech Republic; University of Oslo; Lund University; Universitaire Ziekenhuizen KU Leuven; Tufts University; University of Copenhagen; University College Dublin; Newcastle University; University of Eastern Finland; University of Barcelona; Humboldt-Universität zu Berlin; University of Graz; Agroscope Liebefeld-Posieux Research Station ALP; NIHS; Technical University Munchen; NuGo; VITAS Analytical Services; CSIRO Animal, Food and Health Sciences; SwissAnalysis AG; CRA NUT - Centro di Ricerca per gli Alimenti e la Nutrizione
• Investigators: Principal Investigator: André Boorsma, PhD, TNO; Principal Investigator: Baukje de Roos, Newcastle University; Principal Investigator: Giuditta Perozzi, CRA-NUT; Principal Investigator: Lorraine Brennan, University College Dublin; Principal Investigator: Christophe Matthys, University Leuven; Principal Investigator: Irina Dobre, University of Copenhagen; Principal Investigator: Miroslav Petr, Charles University Prague; Principal Investigator: Andre Mazur, INRA - French National Institute for Agricultural Research; Principal Investigator: Guy Vergères, PhD Dr, Agroscope Liebefeld-Posieux Research Station ALP; Principal Investigator: Marjukka Kolehmainen, University of Eastern Finland; Principal Investigator: Sandra Wallner, Med Uni Graz; Principal Investigator: Cristina Andres-Lacueva, University of Barcelona

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: cohort studies; data collection; personal health records; personal health services; do-it-yourself; nutrition researchers; databases, factual; self-quantification methods
• Other Study ID Numbers: P9616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

An internal review board, consisting of Principal Investigators from all participating countries, will review all data requests.

A data request format is available that should be used for filing such a request. The format requires stating the research questions that should be answered with the requested data, type of data, populations requirements (exclusion criteria), data analysis and public disclosure.

All study participants have the ability to withdraw their data from use for answering specific research questions at any time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No