protocolSection identificationModule nctId: NCT06323538, orgStudyIdInfo id: 01, briefTitle: Cohort Study on Plant-based Diets (COPLANT Study), acronym: COPLANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2047-03-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: German Federal Institute for Risk Assessment, class: OTHER, collaborators name: Max Rubner-Institut, collaborators name: University of Bonn, collaborators name: Research Institute for Plant-Based Nutrition, collaborators name: University of Jena, collaborators name: University of Regensburg, collaborators name: Heidelberg University, collaborators name: University of Vienna, descriptionModule briefSummary: 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., conditionsModule conditions: Dietary Exposure, conditions: Diabetes Mellitus, Type 2, conditions: Cardiovascular Diseases, conditions: Bone Loss, conditions: Sustainability, conditions: Exposure, conditions: Obesity, conditions: Vitamin Deficiency, conditions: Mineral Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Incidence of diabetes type 2, secondaryOutcomes measure: Incidence of cardiovascular diseases, secondaryOutcomes measure: Incidence of cancer, secondaryOutcomes measure: Vitamin B12, secondaryOutcomes measure: Holo-transcobalamine, secondaryOutcomes measure: Homocysteine, secondaryOutcomes measure: Methylmalonic acid, secondaryOutcomes measure: Vitamin B1 status, secondaryOutcomes measure: Vitamin B2 status, secondaryOutcomes measure: Vitamin B6 status, secondaryOutcomes measure: Vitamin C status, secondaryOutcomes measure: Vitamin D status, secondaryOutcomes measure: Vitamin E status, secondaryOutcomes measure: Iron, secondaryOutcomes measure: Ferritin, secondaryOutcomes measure: Transferrin, secondaryOutcomes measure: Zinc status, secondaryOutcomes measure: Selenium status, secondaryOutcomes measure: Iodine status, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Blood lipids, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: C-peptide, secondaryOutcomes measure: Osteocalcin, secondaryOutcomes measure: Ostase, secondaryOutcomes measure: Parathormone, secondaryOutcomes measure: N-terminal propeptide of type I procollagen (PINP), secondaryOutcomes measure: C-terminal telopeptide of type I collagen (CTX), secondaryOutcomes measure: Creatinine, secondaryOutcomes measure: Uric acid, secondaryOutcomes measure: Cytstatin C, secondaryOutcomes measure: Thyroid stimulating hormone (TSH), secondaryOutcomes measure: Free triiodothyronine (fT3), secondaryOutcomes measure: Free thyroxine (fT4), secondaryOutcomes measure: Body fat, secondaryOutcomes measure: Skeletal muscle mass, secondaryOutcomes measure: Total Body Water, secondaryOutcomes measure: Energy intake, secondaryOutcomes measure: Nutrient intake, secondaryOutcomes measure: Intake of dietary supplements, secondaryOutcomes measure: Intake of medication, otherOutcomes measure: Heavy metals, otherOutcomes measure: Halogenated, polycyclic aromatic hydrocarbons (dioxins), otherOutcomes measure: Mycotoxins, otherOutcomes measure: Per- and polyfluoroalkyl substances (PFAS), otherOutcomes measure: Microbiome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Vienna, city: Vienna, zip: 1090, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Max Rubner-Institut, city: Karlsruhe, state: Baden-Württemberg, zip: 76131, country: Germany, contacts name: Benedikt Merz, PhD, role: CONTACT, email: benedikt.merz@mri.bund.de, geoPoint lat: 49.00937, lon: 8.40444, locations facility: Friedrich-Schiller University, city: Jena, state: Thuringia, zip: 07743, country: Germany, contacts name: Christine Dawczynski, PhD, role: CONTACT, phone: +49 3641 949656, email: christine.dawczynski@uni-jena.de, geoPoint lat: 50.92878, lon: 11.5899, locations facility: The German Federal Institut for Risk Assessment, city: Berlin, zip: 10589, country: Germany, contacts name: Cornelia Weikert, Prof, role: CONTACT, phone: +49 30 1841255000, email: Cornelia.Weikert@bfr.bund.de, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Bonn, city: Bonn, country: Germany, contacts name: Ute Nöthlings, Prof, role: CONTACT, email: noethlings@uni-bonn.de, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Research Institute for Plant-Based Nutrition, Gießen, city: Gießen, zip: 35444, country: Germany, contacts name: Markus Keller, PhD, role: CONTACT, email: keller@ifpe-giessen.de, geoPoint lat: 50.58727, lon: 8.67554, locations facility: University Heidelberg, city: Heidelberg, zip: 69120, country: Germany, contacts name: Ina Danquah, role: CONTACT, email: ina.danquah@uni-heidelberg.de, geoPoint lat: 49.40768, lon: 8.69079, locations facility: University Regensburg, city: Regensburg, zip: 93053, country: Germany, contacts name: Michael Leitzmann, Prof, role: CONTACT, email: Michael.Leitzmann@klinik.uni-regensburg.de, contacts name: Beate Fischer, role: CONTACT, email: Beate.Fischer@klinik.uni-regensburg.de, geoPoint lat: 49.01513, lon: 12.10161, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-20, uploadDate: 2024-02-23T09:43, filename: Prot_000.pdf, size: 1528917, hasResults: False