The Nutrition Researcher Cohort 2014 Study (NRC250)
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ClinicalTrials.gov Identifier: NCT02522390 |
Recruitment Status :
Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : April 26, 2017
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Tracking Information | |||||||||||||||||||||||||||||||||||||
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First Submitted Date | March 23, 2015 | ||||||||||||||||||||||||||||||||||||
First Posted Date | August 13, 2015 | ||||||||||||||||||||||||||||||||||||
Last Update Posted Date | April 26, 2017 | ||||||||||||||||||||||||||||||||||||
Study Start Date | January 2015 | ||||||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | January 2025 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||||||||||||||||||||||||||||||
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Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||||||||
Brief Title | 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 | ||||||||||||||||||||||||||||||||||||
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. |
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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). |
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Study Type | Observational | ||||||||||||||||||||||||||||||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||||||||||||||
Biospecimen | Retention: Samples With DNA Description: "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:
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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. | ||||||||||||||||||||||||||||||||||||
Condition |
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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. Other Names:
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Study Groups/Cohorts | 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.
Intervention: Other: Research activities
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Publications * | Not Provided | ||||||||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||||||||
Recruitment Status | Active, not recruiting | ||||||||||||||||||||||||||||||||||||
Actual Enrollment |
192 | ||||||||||||||||||||||||||||||||||||
Original Estimated Enrollment |
250 | ||||||||||||||||||||||||||||||||||||
Estimated Study Completion Date | January 2025 | ||||||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | January 2025 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||
Listed Location Countries | Austria, Belgium, Czechia, Denmark, Finland, France, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom | ||||||||||||||||||||||||||||||||||||
Removed Location Countries | Czech Republic, United States | ||||||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||||||
NCT Number | NCT02522390 | ||||||||||||||||||||||||||||||||||||
Other Study ID Numbers | P9616 | ||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Ivana Bobeldijk-Pastorova, TNO | ||||||||||||||||||||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||||||||||||||||||||
Current Study Sponsor | TNO | ||||||||||||||||||||||||||||||||||||
Original Study Sponsor | Same as current | ||||||||||||||||||||||||||||||||||||
Collaborators |
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Investigators |
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PRS Account | TNO | ||||||||||||||||||||||||||||||||||||
Verification Date | April 2017 |