AzTrials
AzTrials

Dietary ExposureCOPLANTNCT06323538

Cohort Study on Plant-based Diets (COPLANT Study)

An observational study of Dietary Exposure and Diabetes Mellitus, Type 2, run by German Federal Institute for Risk Assessment at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 69 years
How many people
6,000 participants
Where
8 sitesin 2 countries
Study dates
9 Apr 2024to 31 Mar 2047
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • Adult, Older adult

Study population: Vegans - no consumption of animal products (less than one exception per month) Vegetarians * no consumption of meat and fish (less than one exception per month) * consumption of eggs and/or dairy products (at least once a month) Pescetarians * no consumption of meat (less than one exception per month) * consumption of fish (at least once a month) * consumption of eggs or dairy products possible Omnivores/ mixed diet - group of non-exposed persons or control group - consumption of meat or sausage (at least once a month).

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • who can no longer be contacted
  • who withdraw their consent to participate in the study

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Cornelia Weikert, Prof contact

+49 30 184155000

Cornelia.Weikert@bfr.bund.de

Christine Dawczynski, PhD contact

+49 3641 949656

christine.dawczynski@uni-jena.de

8 sites in 2 countries

Germany7 sites, 7 recruiting

  • The German Federal Institut for Risk Assessment

    Berlin, 10589

    Cornelia Weikert, Prof, +49 30 1841255000, Cornelia.Weikert@bfr.bund.de

    Recruiting

  • University Bonn

    Bonn

    Ute Nöthlings, Prof, noethlings@uni-bonn.de

    Recruiting

  • Research Institute for Plant-Based Nutrition, Gießen

    Giessen, 35444

    Markus Keller, PhD, keller@ifpe-giessen.de

    Not yet recruiting

  • University Heidelberg

    Heidelberg, 69120

    Ina Danquah, ina.danquah@uni-heidelberg.de

    Not yet recruiting

  • Friedrich-Schiller University

    Jena, Thuringia, 07743

    Christine Dawczynski, PhD, +49 3641 949656, christine.dawczynski@uni-jena.de

    Recruiting

  • Max Rubner-Institut

    Karlsruhe, Baden-Wurttemberg, 76131

    Benedikt Merz, PhD, benedikt.merz@mri.bund.de

    Recruiting

  • University Regensburg

    Regensburg, 93053

    Michael Leitzmann, Prof, Michael.Leitzmann@klinik.uni-regensburg.de

    Beate Fischer, Beate.Fischer@klinik.uni-regensburg.de

    Recruiting

Other trials in Germany

Austria1 site, 1 recruiting

  • University Vienna

    Vienna, 1090

    Maria Wakolbinger, Prof, maria.wakolbinger@meduniwien.ac.at

    Tilman Kühn, Prof, tilman.kuehn@univie.ac.at

    Recruiting

Other trials in Austria

About this study

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.

Read the 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 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.

Keywords
vegan, vegetarian, pescetarian, omnivor, multicenter cohort, biomarker, vitamins, minerals, bone health, cardiovascular risk, body composition, inflammation, contaminants, diabetes type 2, thyroid gland health, microbiota, metabolomics, adults, children, pregnancy
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Bone Diseases, Metabolic, Obesity, Avitaminosis, Inflammation, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06323538
Study groupRoleWhat they receive
vegansvegan diet: no products of animal origin
vegetariansvegetarian diet: no meat and fish, but dairy products and eggs
pescetarianspescetarian diet: no meat, but fish
mixed dietmixed diet: plant-based foods and animal-based foods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of diabetes type 2

    Incidence of diabetes type 2

    Measured: 5, 10, 20 years

Secondary outcomes (42)

  1. Incidence of cardiovascular diseases

    Incidence of cardiovascular diseases

    Measured: 10, 20 years

  2. Incidence of cancer

    Incidence of cancer

    Measured: 10, 20 years

  3. Vitamin B12

    Vitamin B12 (pmol/l)

    Measured: Baseline

  4. Holo-transcobalamine

    Holo-transcobalamine (pmol/l),

    Measured: Baseline

  5. Homocysteine

    Homocysteine (µmol/l)

    Measured: Baseline

  6. Methylmalonic acid

    Methylmalonic acid (µg/l)

    Measured: Baseline

  7. Vitamin B1 status

    Vitamin B1 (nmol/l)

    Measured: Baseline

  8. Vitamin B2 status

    Vitamin B2 (µg/l)

    Measured: Baseline

  9. Vitamin B6 status

    Vitamin B6 (nmol/l)

    Measured: Baseline

  10. Vitamin C status

    Vitamin C (mg/l)

    Measured: Baseline

  11. Vitamin D status

    Vitamin D (nmol/l)

    Measured: Baseline

  12. Vitamin E status

    Vitamin E (µmol/l)

    Measured: Baseline

  13. Iron

    Iron (µmol/l)

    Measured: Baseline

  14. Ferritin

    Ferritin (µg/l)

    Measured: Baseline

  15. Transferrin

    Transferrin (mg/dl)

    Measured: Baseline

  16. Zinc status

    Zinc (µg/l)

    Measured: Baseline

  17. Selenium status

    Selenium (µg/l)

    Measured: Baseline

  18. Iodine status

    Iodine (µg/l)

    Measured: Baseline

  19. Blood pressure

    Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg)

    Measured: Baseline

  20. Blood lipids

    Total cholesterol, LDL, HDL, triacylglycerides (mmol/l)

    Measured: Baseline

  21. Fasting insulin

    Fasting insulin (mU/l)

    Measured: Baseline

  22. Fasting glucose

    Fasting glucose (mmol/l)

    Measured: Baseline

  23. Glycated hemoglobin (HbA1c)

    HbA1c (%)

    Measured: Baseline

  24. C-peptide

    C-peptide (ng/ml)

    Measured: Baseline

  25. Osteocalcin

    Osteocalcin (ng/ml)

    Measured: Baseline

  26. Ostase

    Ostase (µg/l)

    Measured: Baseline

  27. Parathormone

    Parathormone (ng/l)

    Measured: Baseline

  28. N-terminal propeptide of type I procollagen (PINP)

    PINP (ng/ml)

    Measured: Baseline

  29. C-terminal telopeptide of type I collagen (CTX)

    CTX (ng/ml)

    Measured: Baseline

  30. Creatinine

    Creatinine (mmol/24h)

    Measured: Baseline

  31. Uric acid

    Uric acid (mg/24h)

    Measured: Baseline

  32. Cytstatin C

    Cytstatin C (mg/l)

    Measured: Baseline

  33. Thyroid stimulating hormone (TSH)

    TSH (mU/l)

    Measured: Baseline

  34. Free triiodothyronine (fT3)

    fT3 (pmol/l)

    Measured: Baseline

  35. Free thyroxine (fT4)

    fT4 (pmol/l)

    Measured: Baseline

  36. Body fat

    Body fat (kg)

    Measured: Baseline

  37. Skeletal muscle mass

    Skeletal muscle mass (kg)

    Measured: Baseline

  38. Total Body Water

    Total Body Water (l)

    Measured: Baseline

  39. Energy intake

    Calories per day

    Measured: Baseline

  40. Nutrient intake

    Milligramm per day

    Measured: Baseline

  41. Intake of dietary supplements

    Frequencies per day

    Measured: Baseline

  42. Intake of medication

    Frequencies per day

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start9 Apr 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2047 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06323538
Sponsor's protocol ID
01
Acronym
COPLANT
Status last verified
Feb 2025
First submitted
1 Mar 2024
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: In accordance with the informed consent of the COPLANT participants, pseudonymised study data could be provided to external researchers upon request for cooperation or data-use purposes. In this case, a cooperation or data use agreement must be concluded in advance. The use of COPLANT study data is therefore only possible with a detailed prior justification of its scientific purpose and after agreement of the steering commitee of the COPLANT study.

Questions about this trial

What is this clinical trial studying?

An observational study of Dietary Exposure and Diabetes Mellitus, Type 2, run by German Federal Institute for Risk Assessment at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cornelia Weikert, Prof (+49 30 184155000, Cornelia.Weikert@bfr.bund.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of diabetes type 2 (time frame: 5, 10, 20 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06323538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in