The Nutrition Researcher Cohort 2014 Study

NCT02522390 | Unknown

• 1 other identifier: P9616
• Study Type: observational
• Target: 192
• Locations: 12 countries
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (13)

• 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

• 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

• 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

  once per year during entire cohort (Month 12, M24, M36, M48, M60)

Other Outcomes (2)

• compliance with the study protocol

  after one year (june 2016)

• user experiences with participating in the cohort

  after one year (june 2016)

Study Arms (1)

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

Interventions

Research activities 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.

Also known as: Do-it-yourself devices, filling out online-questionnaires, sample collection with supplied kits

Nutrition Researcher Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (12)

Medizinische Universität Graz

Graz, A-8036, Austria

Location

University of Leuven (KU Leuven)

Leuven, Belgium

Location

Charles University Prague

Prague, Czechia

Location

University of Copenhagen

Copenhagen, Denmark

Location

University of Eastern Finland

Kuopio, FI-70210, Finland

Location

INRA - L'Institut Nationel de la Recherche Agronomique

Clermont, France

Location

University College Dublin

Dublin, Ireland

Location

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

Rome, 00178, Italy

Location

TNO

Zeist, Gelderland, Netherlands

Location

University of Barcelona

Barcelona, Spain

Location

Agroscope, Institute for Food Sciences

Bern, Switzerland

Location

Newcastle University

Newcastle, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

"do-it-yourself", at-home measurements of blood glucose and blood cholesterol. In addition, the plasma metabolome and selected biomarkers (from dried blood spot), urinary metabolome (from collected urine), DNA damage (from dried blood spots, telomere length and mitochondrial DNA deletions, DNA base damage/oxidation, gamma H2AX DNA strand break assay), micronutrient analysis (from dried blood spot or capillary blood collection) and microbiome (sequencing metagenomics/Fecal Swabs) will be offered to participants as additional measurements, if funding or in-kind sponsoring is available. Funding is already available for: * Dried blood spot collection for analysis of biomarkers (including fatty acids, vitamins, amino acids) and metabolomics; * Faecal collection (swab) for metagenome analysis * Capillary blood collection for CRP, HbA1c and other parameters * OGTT sampling kit for analysis of insulin and c-peptide;

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: August 13, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); ES (1); GB (1); IT (1); CH (1); AU (1); CZ (1); DK (1); FI (1); IE (1); BE (1); FR (1)