Postprandial Inflammation in Rheumatoid Arthritis
NCT04247009
Arthritis, Arthritis, Rheumatoid
Gothenburg, Not in US/Canada, Sweden
View Trial DetailsNCT Number: NCT06323538
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.
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Request Info18 year–69 year
All sexes
Observational
University Vienna, Vienna, Austria
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5, 10, 20 years
Incidence of diabetes type 2
Time frame: 10, 20 years
Incidence of cardiovascular diseases
Time frame: 10, 20 years
Incidence of cancer
Time frame: Baseline
Vitamin B12 (pmol/l)
Time frame: Baseline
Holo-transcobalamine (pmol/l),
Time frame: Baseline
Homocysteine (µmol/l)
Time frame: Baseline
Methylmalonic acid (µg/l)
Time frame: Baseline
Vitamin B1 (nmol/l)
Time frame: Baseline
Vitamin B2 (µg/l)
Time frame: Baseline
Vitamin B6 (nmol/l)
Time frame: Baseline
Vitamin C (mg/l)
Time frame: Baseline
Vitamin D (nmol/l)
Time frame: Baseline
Vitamin E (µmol/l)
Time frame: Baseline
Iron (µmol/l)
Time frame: Baseline
Ferritin (µg/l)
Time frame: Baseline
Transferrin (mg/dl)
Time frame: Baseline
Zinc (µg/l)
Time frame: Baseline
Selenium (µg/l)
Time frame: Baseline
Iodine (µg/l)
Time frame: Baseline
Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg)
Time frame: Baseline
Total cholesterol, LDL, HDL, triacylglycerides (mmol/l)
Time frame: Baseline
Fasting insulin (mU/l)
Time frame: Baseline
Fasting glucose (mmol/l)
Time frame: Baseline
HbA1c (%)
Time frame: Baseline
C-peptide (ng/ml)
Time frame: Baseline
Osteocalcin (ng/ml)
Time frame: Baseline
Ostase (µg/l)
Time frame: Baseline
Parathormone (ng/l)
Time frame: Baseline
PINP (ng/ml)
Time frame: Baseline
CTX (ng/ml)
Time frame: Baseline
Creatinine (mmol/24h)
Time frame: Baseline
Uric acid (mg/24h)
Time frame: Baseline
Cytstatin C (mg/l)
Time frame: Baseline
TSH (mU/l)
Time frame: Baseline
fT3 (pmol/l)
Time frame: Baseline
fT4 (pmol/l)
Time frame: Baseline
Body fat (kg)
Time frame: Baseline
Skeletal muscle mass (kg)
Time frame: Baseline
Total Body Water (l)
Time frame: Baseline
Calories per day
Time frame: Baseline
Milligramm per day
Time frame: Baseline
Frequencies per day
Time frame: Baseline
Frequencies per day
Time frame: Baseline
Arsenic, lead, cadmium (µg/l)
Time frame: Baseline
Dioxins (ng/g lipid)
Time frame: Baseline
Mycotoxins (ng/ml)
Time frame: Baseline
PFAS (ng/ml)
Time frame: Baseline
16S rRNA sequencing
Contact information is provided by the study sponsor or research team.
Christine Dawczynski, PhD
CONTACT
Cornelia Weikert, Prof
CONTACT
German Federal Institute for Risk Assessment
Other
Acronym: COPLANT
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.
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