The Nutrition Researcher Cohort 2014 Study

Health Clinical Trial

— NRC250  

Official title:

The Nutrition Researcher Cohort 2014 Study; New Standardized Self-quantification Methodologies Serving Both Research and Personal Health Maintenance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02522390
• Other study ID #: P9616
• Status: Active, not recruiting
• Phase: N/A
• First received: March 23, 2015
• Last updated: April 24, 2017
• Start date: January 2015
• Est. completion date: January 2025

Study information

• Verified date: April 2017
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 192
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Biological Markers
• Health
• Nutritional Physiological Phenomena

Intervention

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.

Locations

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

Sponsors (21)

Lead Sponsor

Collaborator

TNO

Agroscope Liebefeld-Posieux Research Station ALP, Charles University, Czech Republic, CRA NUT - Centro di Ricerca per gli Alimenti e la Nutrizione, CSIRO Animal, Food and Health Sciences, Humboldt-Universität zu Berlin, Lund University, Newcastle University, NIHS, NuGo, SwissAnalysis AG, Technical University Munchen, Tufts University, Universitaire Ziekenhuizen Leuven, University College Dublin, University of Barcelona, University of Copenhagen, University of Eastern Finland, University of Graz, University of Oslo, VITAS Analytical Services

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	user experiences with participating in the cohort	as measured via a questionnaire	after one year (june 2016)
Primary	Body height	measured with do-it-yourself device in at-home setting	Baseline (week 1)
Primary	Body weight	measured with do-it-yourself device in at-home setting	Each week during entire cohort (five years in total)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	general health status	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	lifestyle (smoking, alcohol consumption, etc.)	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	general food intake	via a food frequency questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	quality of sleep	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	stress questionnaire		once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	physical activity	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	wellness	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	cognition	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)
Secondary	quality of life	via a questionnaire	once per year during entire cohort (Month 12, M24, M36, M48, M60)