Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2024-04-09
2047-03-31
Brief Summary
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Detailed Description
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The detailed consumption survey of all study participants is one of the main pillars of the planned study. Of particular importance is the dietary assessment of novel vegan and vegetarian foods, thus an app adapted to the needs of this study was developed. The characterisation of external and internal intakes of nutrients and contaminants within a particular diet will be examined. Large epidemiological projects currently underway in Germany, such as the NAKO Health Study, are unable to answer these questions. In order to prospectively investigate links between diet and the later occurrence of common diseases such as type 2 diabetes, cardiovascular diseases and cancer, the study participants should be followed up for at least 20 years if third-party funding is successfully acquired.
The study is to be conducted in study centers at the Federal Institute for Risk Assessment (BfR), Berlin, the Max Rubner-Institut (MRI) in Karlsruhe, the Rheinische Friedrich-Wilhelms University in Bonn, the Friedrich Schiller University Jena, the Research Institute for Plant-Based Nutrition in Giessen, in cooperation with the Justus Liebig University Giessen and at the universities of Heidelberg, Regensburg and Vienna. Furthermore, the basic examination includes measurements of body composition, bone health, cardiovascular risk factors, diabetes risk, contaminants and lifestyle. Specific aspects of dietary behavior, physical activity and other lifestyle factors will be assessed using questionnaires. For the basic laboratory program, fasting blood, 24-hour urine collection and a stool sample are taken from all study participants.
Participants will be recruited for the baseline study from 2024 to 2027. Follow-up visits are planned at intervals of 5, 10 and 20 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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vegans
vegan diet: no products of animal origin
No interventions assigned to this group
vegetarians
vegetarian diet: no meat and fish, but dairy products and eggs
No interventions assigned to this group
pescetarians
pescetarian diet: no meat, but fish
No interventions assigned to this group
mixed diet
mixed diet: plant-based foods and animal-based foods
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* following their current diet for at least one year
* health insured
* are willing to have blood taken (adults)
* are willing and able to complete questionnaires
* only at Berlin, Jena, Giessen and Karlsruhe sites: pregnant and breastfeeding women were recruited (shortened examination programm)
* only at the Regensburg, Heidelberg, Bonn and Vienna sites: are neither pregnant nor breastfeeding at the time of recruitment
* only at Berlin and Karlsruhe sites: children of adult participants (shortened examination programm without collection of blood, urine, and stool)
* are able to give informed consent to participate in the study
* have given their consent to participate in the COPLANT study
Exclusion Criteria
* who withdraw their consent to participate in the study
18 Years
69 Years
ALL
No
Sponsors
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Max Rubner-Institut
UNKNOWN
University of Bonn
OTHER
Research Institute for Plant-Based Nutrition
UNKNOWN
University of Jena
OTHER
University of Regensburg
OTHER
Heidelberg University
OTHER
University of Vienna
OTHER
German Federal Institute for Risk Assessment
OTHER
Responsible Party
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Principal Investigators
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Ute Nöthlings, Prof
Role: PRINCIPAL_INVESTIGATOR
University Bonn
Christine Dawczynski, PhD
Role: PRINCIPAL_INVESTIGATOR
University Jena
Markus Keller, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Institute for Plant-based Nutrition (IFPE)
Michael Leitzmann, Prof
Role: PRINCIPAL_INVESTIGATOR
University Regensburg
Ina Danquah, Prof
Role: PRINCIPAL_INVESTIGATOR
University Heidelberg
Maria Wakolbinger, Prof
Role: PRINCIPAL_INVESTIGATOR
University Vienna
Tilman Kühn, Prof
Role: PRINCIPAL_INVESTIGATOR
University Vienna
Beate Fischer, PhD
Role: PRINCIPAL_INVESTIGATOR
University Regensburg
Benedikt Merz, PhD
Role: PRINCIPAL_INVESTIGATOR
Max Rubner-Institut
Cornelia Weikert, Prof
Role: PRINCIPAL_INVESTIGATOR
Federal Institut for Risk Assessment
Locations
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University Vienna
Vienna, , Austria
Max Rubner-Institut
Karlsruhe, Baden-Wurttemberg, Germany
Friedrich-Schiller University
Jena, Thuringia, Germany
The German Federal Institut for Risk Assessment
Berlin, , Germany
University Bonn
Bonn, , Germany
Research Institute for Plant-Based Nutrition, Gießen
Giessen, , Germany
University Heidelberg
Heidelberg, , Germany
University Regensburg
Regensburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Related Links
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Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id
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