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Human Study Centre Consumer Health Protection

In the Human Study Centre Consumer Health Protection, human studies, in particular epidemiological studies, are planned, conducted and analyzed in cooperation with the various departments of BfR to generate data with high relevance for risk assessment. By conducting human studies, the Human Study Center contributes to improving risk assessment and thus consumer health protection.

The planning of studies up to the data analysis of different studies is usually carried out in joint responsibility of the Human Study Center and thematically responsible BfR expert groups, as well as external cooperation partners.

Human data make an important contribution to risk assessment because they are obtained directly with humans and thus provide relevant and accurate information about health risks and benefits derived from the diversity of human populations. The Human Studies Center is working to further develop assessment approaches so that the results from human studies can be further incorporated into risk assessment to better inform evidence generation in risk assessment.

An interdisciplinary team of scientific staff and technical specialists works at the Human Study Center. It comprehensively covers various scientific expertise such as medicine, nutritional sciences, epidemiology, toxicology, biostatistics and informatics.

Current studies

RBVD Study

The RBVD (Risks and Benefits of a Vegan Diet) study is a cross-sectional study of 36 vegans and 36 omnivores. The 72 participants in the study underwent extensive assessments at the study center from January to July 2017. These included questionnaires on lifestyle and diseases encountered, detailed dietary survey, measurement of bone health and blood pressure, and collection of anthropometric body measurements, etc. Biosamples (blood, urine, stool) were additionally collected. The Human Study Center is using the data from the study in a variety of ways to gain new insights into the risks and benefits of the vegan diet. In 2021, the RBVD 2 study conducted follow-up of study participants.

COPLANT study

The multicenter COPLANT study (COhort on Plant-based Diets) investigates the health benefits as well as short-term and long-term risks of different plant-based diets (vegan, vegetarian, pescetarian) compared to an omnivorous diet. With seven participating scientific institutions, BfR plans to include a total of approximately 6000 men and women aged 18-69 years in this study. Recruitment of study participants will start in 2023. There will be extensive data collection, including a detailed dietary assessment, as well as the collection of lifestyle factors, health parameters, but also the measurement of blood pressure, physical fitness and bone health. In addition, biospecimens (blood, urine, stool) will be collected.

Further information can be found on the BfR's COPLANT website ( https://www.bfr.bund.de/de/coplant-studie.html).

EDKAR study

The EDKAR study ("Study on Chronic High Consumption of Energy Drinks and Cardiovascular Risk in Adolescents") is conducted in cooperation with Charité Universitätsmedizin Berlin and investigates whether chronic high consumption of energy drinks is associated with cardiovascular changes in adolescents. The study is divided into two study phases. In the first study phase, approximately 5,000 students aged 15 to 18 years will be interviewed via an online survey about their energy drink consumption and other lifestyle factors. In this way, adolescents with chronic high consumption and a control group (non-consumers) will be identified, who will be comprehensively examined cardiologically in the second study phase.

Further information can be found on the EDKAR website of the BfR ( https://www.bfr.bund.de/de/edkar.html).

PFAS study in EPIC-Potsdam

With the PFAS study, the Human Study Center in cooperation with the German Institute of Human Nutrition Potsdam-Rehbrücke (DIfE) investigates the associations between concentrations of per- and polyfluoroalkyl substances (PFAS) in the blood and the risk of developing myocardial infarction, stroke, heart failure and type 2 diabetes in the European Prospective Investigation into Cancer and Nutrition study (EPIC)-Potsdam study. In addition, cross-sectional associations between concentrations of PFAS and biomarkers of lipid metabolism, glucose metabolism, and liver metabolism are being investigated.

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