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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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 6000
Est. completion date March 31, 2047
Est. primary completion date March 31, 2027
Accepts healthy volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria: - age between 18 and 69 years at recruitment (age-stratified recruitment in four age groups (18 to 29, 30 to 39, 40 to 49 and 50 to 69 years) which should be equally distributed across the four diets) - 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 can no longer be contacted - who withdraw their consent to participate in the study

Study Design


Locations

Country Name City State
Austria University Vienna Vienna
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 Friedrich-Schiller University Jena Thuringia
Germany Max Rubner-Institut Karlsruhe Baden-Württemberg
Germany University Regensburg Regensburg

Sponsors (8)

Lead Sponsor Collaborator
German Federal Institute for Risk Assessment Heidelberg University, Max Rubner-Institut, Research Institute for Plant-Based Nutrition, University of Bonn, University of Jena, University of Regensburg, University of Vienna

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Heavy metals Arsenic, lead, cadmium (µg/l) Baseline
Other Halogenated, polycyclic aromatic hydrocarbons (dioxins) Dioxins (ng/g lipid) Baseline
Other Mycotoxins Mycotoxins (ng/ml) Baseline
Other Per- and polyfluoroalkyl substances (PFAS) PFAS (ng/ml) Baseline
Other Microbiome 16S rRNA sequencing Baseline
Primary Incidence of diabetes type 2 Incidence of diabetes type 2 5, 10, 20 years
Secondary Incidence of cardiovascular diseases Incidence of cardiovascular diseases 10, 20 years
Secondary Incidence of cancer Incidence of cancer 10, 20 years
Secondary Vitamin B12 Vitamin B12 (pmol/l) Baseline
Secondary Holo-transcobalamine Holo-transcobalamine (pmol/l), Baseline
Secondary Homocysteine Homocysteine (µmol/l) Baseline
Secondary Methylmalonic acid Methylmalonic acid (µg/l) Baseline
Secondary Vitamin B1 status Vitamin B1 (nmol/l) Baseline
Secondary Vitamin B2 status Vitamin B2 (µg/l) Baseline
Secondary Vitamin B6 status Vitamin B6 (nmol/l) Baseline
Secondary Vitamin C status Vitamin C (mg/l) Baseline
Secondary Vitamin D status Vitamin D (nmol/l) Baseline
Secondary Vitamin E status Vitamin E (µmol/l) Baseline
Secondary Iron Iron (µmol/l) Baseline
Secondary Ferritin Ferritin (µg/l) Baseline
Secondary Transferrin Transferrin (mg/dl) Baseline
Secondary Zinc status Zinc (µg/l) Baseline
Secondary Selenium status Selenium (µg/l) Baseline
Secondary Iodine status Iodine (µg/l) Baseline
Secondary Blood pressure Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg) Baseline
Secondary Blood lipids Total cholesterol, LDL, HDL, triacylglycerides (mmol/l) Baseline
Secondary Fasting insulin Fasting insulin (mU/l) Baseline
Secondary Fasting glucose Fasting glucose (mmol/l) Baseline
Secondary Glycated hemoglobin (HbA1c) HbA1c (%) Baseline
Secondary C-peptide C-peptide (ng/ml) Baseline
Secondary Osteocalcin Osteocalcin (ng/ml) Baseline
Secondary Ostase Ostase (µg/l) Baseline
Secondary Parathormone Parathormone (ng/l) Baseline
Secondary N-terminal propeptide of type I procollagen (PINP) PINP (ng/ml) Baseline
Secondary C-terminal telopeptide of type I collagen (CTX) CTX (ng/ml) Baseline
Secondary Creatinine Creatinine (mmol/24h) Baseline
Secondary Uric acid Uric acid (mg/24h) Baseline
Secondary Cytstatin C Cytstatin C (mg/l) Baseline
Secondary Thyroid stimulating hormone (TSH) TSH (mU/l) Baseline
Secondary Free triiodothyronine (fT3) fT3 (pmol/l) Baseline
Secondary Free thyroxine (fT4) fT4 (pmol/l) Baseline
Secondary Body fat Body fat (kg) Baseline
Secondary Skeletal muscle mass Skeletal muscle mass (kg) Baseline
Secondary Total Body Water Total Body Water (l) Baseline
Secondary Energy intake Calories per day Baseline
Secondary Nutrient intake Milligramm per day Baseline
Secondary Intake of dietary supplements Frequencies per day Baseline
Secondary Intake of medication Frequencies per day Baseline
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