Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323538
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-01
Brief Title:
Cohort Study on Plant-based Diets COPLANT Study
Sponsor:
German Federal Institute for Risk Assessment
Organization:
German Federal Institute for Risk Assessment
Study Overview
Official Title:
Cohort Study on Plant-based Diets COPLANT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPLANT
Brief Summary:
The Cohort on Plant-based Diets COPLANT study is a multi-centre cohort study that starts baseline recruitment from 2024 to 2027 with approximately 6000 participants in Germany and Austria The COPLANT study focuses on vegan no animal products vegetarian no meat and fish but dairy products and eggs pescetarian no meat but fish and omnivorous mixed diet including all possible animal products diets The aim of the COPLANT study is to gain new insights on health benefits and risks as well as social ecological and economic effects of different plant-based diets in comparison to a mixed diet In addition to a detailed dietary survey using an app adapted to the needs of this study the baseline examination includes measurements of body composition bone health cardiovascular risk factors diabetes risk contaminants and lifestyle For the basic laboratory program fasting blood 24-hour urine collection and a stool sample are taken from all study participants Furthermore specific aspects of dietary behavior physical activity and other lifestyle factors are collected via questionnaires Follow-up studies are planned at intervals of 5 10 and 20 years after the baseline visit
Detailed Description:
The multicenter Cohort on Plant-based diets COPLANT study aims to investigate the health benefits as well as short-term and long-term risks of different plant-based diets vegan no animal products vegetarian no meat and fish but dairy products and eggs pescetarian no meat but fish compared to a mixed diet among 6000 participants aged 18 to 69 years across German speaking countries Currently the impact of different diets not only on health effects but also on social ecological and economic factors is becoming increasingly evident in areas of social justice climate change and animal welfare For this reason a sustainability analysis social ecological and economic effects together with findings on health effects will be included in the COPLANT study As plant-based diets especially vegan diets are associated with specific risks and benefits for certain population groups such as pregnant women breastfeeding mothers and children COPLANT will also establish appropriate research structures for these groups and include them in the study
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None