Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06323538 |
Other study ID # |
01 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 1, 2024 |
Est. completion date |
March 31, 2047 |
Study information
Verified date |
March 2024 |
Source |
German Federal Institute for Risk Assessment |
Contact |
Cornelia Weikert, Prof |
Phone |
+49 30 184155000 |
Email |
Cornelia.Weikert[@]bfr.bund.de |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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 6,000 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.
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 6,000 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.