Cohort Study on Plant-based Diets (COPLANT Study)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-69
SponsorGerman Federal Institute for Risk Assessment

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

who can no longer be contacted

who withdraw their consent to participate in the study

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

6,000 Participants
are grouped into 4 trial groups
Group A: vegans
Group B: vegetarians
Group C: pescetarians
Group D: mixed diet

Trial outcomes

Primary outcomes

1

Incidence of diabetes type 2

Incidence of diabetes type 2

Time frame
5, 10, 20 years

Secondary outcomes

1

Incidence of cardiovascular diseases

Incidence of cardiovascular diseases

Time frame
10, 20 years
2

Incidence of cancer

Incidence of cancer

Time frame
10, 20 years
3

Vitamin B12

Vitamin B12 (pmol/l)

Time frame
Baseline
4

Holo-transcobalamine

Holo-transcobalamine (pmol/l),

Time frame
Baseline

Other outcomes

1

Heavy metals

Arsenic, lead, cadmium (µg/l)

Time frame
Baseline
2

Halogenated, polycyclic aromatic hydrocarbons (dioxins)

Dioxins (ng/g lipid)

Time frame
Baseline
3

Mycotoxins

Mycotoxins (ng/ml)

Time frame
Baseline
4

Per- and polyfluoroalkyl substances (PFAS)

PFAS (ng/ml)

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Federal Institute for Risk Assessment

Lead sponsor

Max Rubner-Institut

Collaborator

University of Bonn

Collaborator

Research Institute for Plant-Based Nutrition

Collaborator

University of Jena

Collaborator

University of Regensburg

Collaborator

Heidelberg University

Collaborator

University of Vienna

Collaborator