Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06323538

Cohort Study on Plant-based Diets (COPLANT 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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of diabetes type 2

    Time frame: 5, 10, 20 years

    Incidence of diabetes type 2

Secondary outcomes

  1. Incidence of cardiovascular diseases

    Time frame: 10, 20 years

    Incidence of cardiovascular diseases

  2. Incidence of cancer

    Time frame: 10, 20 years

    Incidence of cancer

  3. Vitamin B12

    Time frame: Baseline

    Vitamin B12 (pmol/l)

  4. Holo-transcobalamine

    Time frame: Baseline

    Holo-transcobalamine (pmol/l),

  5. Homocysteine

    Time frame: Baseline

    Homocysteine (µmol/l)

  6. Methylmalonic acid

    Time frame: Baseline

    Methylmalonic acid (µg/l)

  7. Vitamin B1 status

    Time frame: Baseline

    Vitamin B1 (nmol/l)

  8. Vitamin B2 status

    Time frame: Baseline

    Vitamin B2 (µg/l)

  9. Vitamin B6 status

    Time frame: Baseline

    Vitamin B6 (nmol/l)

  10. Vitamin C status

    Time frame: Baseline

    Vitamin C (mg/l)

  11. Vitamin D status

    Time frame: Baseline

    Vitamin D (nmol/l)

  12. Vitamin E status

    Time frame: Baseline

    Vitamin E (µmol/l)

  13. Iron

    Time frame: Baseline

    Iron (µmol/l)

  14. Ferritin

    Time frame: Baseline

    Ferritin (µg/l)

  15. Transferrin

    Time frame: Baseline

    Transferrin (mg/dl)

  16. Zinc status

    Time frame: Baseline

    Zinc (µg/l)

  17. Selenium status

    Time frame: Baseline

    Selenium (µg/l)

  18. Iodine status

    Time frame: Baseline

    Iodine (µg/l)

  19. Blood pressure

    Time frame: Baseline

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

  20. Blood lipids

    Time frame: Baseline

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

  21. Fasting insulin

    Time frame: Baseline

    Fasting insulin (mU/l)

  22. Fasting glucose

    Time frame: Baseline

    Fasting glucose (mmol/l)

  23. Glycated hemoglobin (HbA1c)

    Time frame: Baseline

    HbA1c (%)

  24. C-peptide

    Time frame: Baseline

    C-peptide (ng/ml)

  25. Osteocalcin

    Time frame: Baseline

    Osteocalcin (ng/ml)

  26. Ostase

    Time frame: Baseline

    Ostase (µg/l)

  27. Parathormone

    Time frame: Baseline

    Parathormone (ng/l)

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

    Time frame: Baseline

    PINP (ng/ml)

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

    Time frame: Baseline

    CTX (ng/ml)

  30. Creatinine

    Time frame: Baseline

    Creatinine (mmol/24h)

  31. Uric acid

    Time frame: Baseline

    Uric acid (mg/24h)

  32. Cytstatin C

    Time frame: Baseline

    Cytstatin C (mg/l)

  33. Thyroid stimulating hormone (TSH)

    Time frame: Baseline

    TSH (mU/l)

  34. Free triiodothyronine (fT3)

    Time frame: Baseline

    fT3 (pmol/l)

  35. Free thyroxine (fT4)

    Time frame: Baseline

    fT4 (pmol/l)

  36. Body fat

    Time frame: Baseline

    Body fat (kg)

  37. Skeletal muscle mass

    Time frame: Baseline

    Skeletal muscle mass (kg)

  38. Total Body Water

    Time frame: Baseline

    Total Body Water (l)

  39. Energy intake

    Time frame: Baseline

    Calories per day

  40. Nutrient intake

    Time frame: Baseline

    Milligramm per day

  41. Intake of dietary supplements

    Time frame: Baseline

    Frequencies per day

  42. Intake of medication

    Time frame: Baseline

    Frequencies per day

Other outcomes

  1. Heavy metals

    Time frame: Baseline

    Arsenic, lead, cadmium (µg/l)

  2. Halogenated, polycyclic aromatic hydrocarbons (dioxins)

    Time frame: Baseline

    Dioxins (ng/g lipid)

  3. Mycotoxins

    Time frame: Baseline

    Mycotoxins (ng/ml)

  4. Per- and polyfluoroalkyl substances (PFAS)

    Time frame: Baseline

    PFAS (ng/ml)

  5. Microbiome

    Time frame: Baseline

    16S rRNA sequencing

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Dawczynski, PhD

CONTACT

[email protected]

+49 3641 949656

Cornelia Weikert, Prof

CONTACT

[email protected]

+49 30 184155000

Sponsors and collaborators

Lead sponsor

German Federal Institute for Risk Assessment

Other

Collaborators

  • Heidelberg University
  • Max Rubner-Institut
  • Research Institute for Plant-Based Nutrition
  • University of Bonn
  • University of Jena
  • University of Regensburg
  • University of Vienna

Registry information

Acronym: COPLANT

Important dates

Study start
2024
Primary completion
2027
Study completion
2047
First posted
Mar 21, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.