Clinical trial NCT06323538: Cohort Study on Plant-based Diets (COPLANT Study)
Official title: Cohort Study on Plant-based Diets (COPLANT Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dietary Exposure
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Bone Loss
Sustainability
Exposure
Obesity
Vitamin Deficiency
Mineral Deficiency
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
breast feeding time
mental health
sustainability
Lead sponsor: German Federal Institute for Risk Assessment
Sponsor class: OTHER
Collaborators: name: Max Rubner-Institut
name: University of Bonn
name: Research Institute for Plant-Based Nutrition
name: University of Jena
name: University of Regensburg
name: Heidelberg University
name: University of Vienna
First posted: 2024-03-21
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of diabetes type 2
timeFrame: 5, 10, 20 years
Secondary outcomes:
measure: Incidence of cardiovascular diseases
timeFrame: 10, 20 years
measure: Incidence of cancer
timeFrame: 10, 20 years
measure: Vitamin B12
timeFrame: Baseline
measure: Holo-transcobalamine
timeFrame: Baseline
measure: Homocysteine
timeFrame: Baseline
measure: Methylmalonic acid
timeFrame: Baseline
measure: Vitamin B1 status
timeFrame: Baseline
measure: Vitamin B2 status
timeFrame: Baseline
measure: Vitamin B6 status
timeFrame: Baseline
measure: Vitamin C status
timeFrame: Baseline
measure: Vitamin D status
timeFrame: Baseline
measure: Vitamin E status
timeFrame: Baseline
measure: Iron
timeFrame: Baseline
measure: Ferritin
timeFrame: Baseline
measure: Transferrin
timeFrame: Baseline
measure: Zinc status
timeFrame: Baseline
measure: Selenium status
timeFrame: Baseline
measure: Iodine status
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Blood lipids
timeFrame: Baseline
measure: Fasting insulin
timeFrame: Baseline
measure: Fasting glucose
timeFrame: Baseline
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline
measure: C-peptide
timeFrame: Baseline
measure: Osteocalcin
timeFrame: Baseline
measure: Ostase
timeFrame: Baseline
measure: Parathormone
timeFrame: Baseline
measure: N-terminal propeptide of type I procollagen (PINP)
timeFrame: Baseline
measure: C-terminal telopeptide of type I collagen (CTX)
timeFrame: Baseline
measure: Creatinine
timeFrame: Baseline
measure: Uric acid
timeFrame: Baseline
measure: Cytstatin C
timeFrame: Baseline
measure: Thyroid stimulating hormone (TSH)
timeFrame: Baseline
measure: Free triiodothyronine (fT3)
timeFrame: Baseline
measure: Free thyroxine (fT4)
timeFrame: Baseline
measure: Body fat
timeFrame: Baseline
measure: Skeletal muscle mass
timeFrame: Baseline
measure: Total Body Water
timeFrame: Baseline
measure: Energy intake
timeFrame: Baseline
measure: Nutrient intake
timeFrame: Baseline
measure: Intake of dietary supplements
timeFrame: Baseline
measure: Intake of medication
timeFrame: Baseline
Other outcomes:
measure: Heavy metals
timeFrame: Baseline
measure: Halogenated, polycyclic aromatic hydrocarbons (dioxins)
timeFrame: Baseline
measure: Mycotoxins
timeFrame: Baseline
measure: Per- and polyfluoroalkyl substances (PFAS)
timeFrame: Baseline
measure: Microbiome
timeFrame: Baseline
Locations:
city: Vienna
country: Austria
facility: University Vienna
city: Karlsruhe
country: Germany
facility: Max Rubner-Institut
state: Baden-Württemberg
city: Jena
country: Germany
facility: Friedrich-Schiller University
state: Thuringia
city: Berlin
country: Germany
facility: The German Federal Institut for Risk Assessment
city: Bonn
country: Germany
facility: University Bonn
city: Gießen
country: Germany
facility: Research Institute for Plant-Based Nutrition, Gießen
city: Heidelberg
country: Germany
facility: University Heidelberg
city: Regensburg
country: Germany
facility: University Regensburg
Study officials:
affiliation: University Bonn
name: Ute Nöthlings, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Jena
name: Christine Dawczynski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute for Plant-based Nutrition (IFPE)
name: Markus Keller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Regensburg
name: Michael Leitzmann, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heidelberg
name: Ina Danquah, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Vienna
name: Maria Wakolbinger, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Vienna
name: Tilman Kühn, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Regensburg
name: Beate Fischer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Max Rubner-Institut
name: Benedikt Merz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Institut for Risk Assessment
name: Cornelia Weikert, Prof
role: PRINCIPAL_INVESTIGATOR
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