Cohort Study on Plant-based Diets (COPLANT Study)

NCT06323538 | Recruiting

• 1 other identifier: 01
• Study Type: observational
• Target: 6,000
• Locations: 2 countries
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of diabetes type 2

  Incidence of diabetes type 2

  5, 10, 20 years

Secondary Outcomes (42)

• Incidence of cardiovascular diseases

  10, 20 years

• Incidence of cancer

  10, 20 years

• Vitamin B12

  Baseline

• Holo-transcobalamine

  Baseline

• Homocysteine

  Baseline

Other Outcomes (5)

• Heavy metals

  Baseline

• Halogenated, polycyclic aromatic hydrocarbons (dioxins)

  Baseline

• Mycotoxins

  Baseline

Study Arms (4)

vegans

vegan diet: no products of animal origin

vegetarians

vegetarian diet: no meat and fish, but dairy products and eggs

pescetarians

pescetarian diet: no meat, but fish

mixed diet

mixed diet: plant-based foods and animal-based foods

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: We plan to include proportions of women and men (ratio 1:1), whereby a proportion of women of up to 60 % is accepted.
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• German Federal Institute for Risk Assessment: lead
• 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

Study Sites (8)

University Vienna

Vienna, 1090, Austria

RECRUITING

Max Rubner-Institut

Karlsruhe, Baden-Wurttemberg, 76131, Germany

RECRUITING

Friedrich-Schiller University

Jena, Thuringia, 07743, Germany

RECRUITING

The German Federal Institut for Risk Assessment

Berlin, 10589, Germany

RECRUITING

University Bonn

Bonn, Germany

RECRUITING

Research Institute for Plant-Based Nutrition, Gießen

Giessen, 35444, Germany

NOT YET RECRUITING

University Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

University Regensburg

Regensburg, 93053, Germany

RECRUITING

Related Links

• summary

Biospecimen

Retention: SAMPLES WITH DNA

fasting blood samples, 24h urine, stool samples, saliva, breast milk

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Bone Diseases, Metabolic; Obesity; Avitaminosis; Inflammation; Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Deficiency Diseases; Malnutrition; Pathologic Processes; Personal Satisfaction; Behavior

Study Officials

• Ute Nöthlings, Prof

  University Bonn

  PRINCIPAL INVESTIGATOR

• Christine Dawczynski, PhD

  University Jena

  PRINCIPAL INVESTIGATOR

• Markus Keller, PhD

  Research Institute for Plant-based Nutrition (IFPE)

  PRINCIPAL INVESTIGATOR

• Michael Leitzmann, Prof

  University Regensburg

  PRINCIPAL INVESTIGATOR

• Ina Danquah, Prof

  University Heidelberg

  PRINCIPAL INVESTIGATOR

• Maria Wakolbinger, Prof

  University Vienna

  PRINCIPAL INVESTIGATOR

• Tilman Kühn, Prof

  University Vienna

  PRINCIPAL INVESTIGATOR

• Beate Fischer, PhD

  University Regensburg

  PRINCIPAL INVESTIGATOR

• Benedikt Merz, PhD

  Max Rubner-Institut

  PRINCIPAL INVESTIGATOR

• Cornelia Weikert, Prof

  Federal Institut for Risk Assessment

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cornelia Weikert, Prof

CONTACT

+49 30 184155000; Cornelia.Weikert@bfr.bund.de

Christine Dawczynski, PhD

CONTACT

+49 3641 949656; christine.dawczynski@uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 21, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2047
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

AU (1); DE (7)