Cohort Study on Plant-based Diets (COPLANT Study)

Obesity Clinical Trial

— COPLANT  

Official title:

Cohort Study on Plant-based Diets (COPLANT Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323538
• Other study ID #: 01
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: March 31, 2047

Study information

• Verified date: March 2024
• Source: German Federal Institute for Risk Assessment
• Contact: Cornelia Weikert, Prof
• Phone: +49 30 184155000
• Email: Cornelia.Weikert[@]bfr.bund.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6000
• Est. completion date: March 31, 2047
• Est. primary completion date: March 31, 2027
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Bone Loss
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Dietary Exposure
• Exposure
• Mineral Deficiency
• Obesity
• Sustainability
• Vitamin Deficiency

Locations

Country	Name	City	State
Austria	University Vienna	Vienna
Germany	The German Federal Institut for Risk Assessment	Berlin
Germany	University Bonn	Bonn
Germany	Research Institute for Plant-Based Nutrition, Gießen	Gießen
Germany	University Heidelberg	Heidelberg
Germany	Friedrich-Schiller University	Jena	Thuringia
Germany	Max Rubner-Institut	Karlsruhe	Baden-Württemberg
Germany	University Regensburg	Regensburg

Sponsors (8)

Lead Sponsor	Collaborator
German Federal Institute for Risk Assessment	Heidelberg University, Max Rubner-Institut, Research Institute for Plant-Based Nutrition, University of Bonn, University of Jena, University of Regensburg, University of Vienna

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heavy metals	Arsenic, lead, cadmium (µg/l)	Baseline
Other	Halogenated, polycyclic aromatic hydrocarbons (dioxins)	Dioxins (ng/g lipid)	Baseline
Other	Mycotoxins	Mycotoxins (ng/ml)	Baseline
Other	Per- and polyfluoroalkyl substances (PFAS)	PFAS (ng/ml)	Baseline
Other	Microbiome	16S rRNA sequencing	Baseline
Primary	Incidence of diabetes type 2	Incidence of diabetes type 2	5, 10, 20 years
Secondary	Incidence of cardiovascular diseases	Incidence of cardiovascular diseases	10, 20 years
Secondary	Incidence of cancer	Incidence of cancer	10, 20 years
Secondary	Vitamin B12	Vitamin B12 (pmol/l)	Baseline
Secondary	Holo-transcobalamine	Holo-transcobalamine (pmol/l),	Baseline
Secondary	Homocysteine	Homocysteine (µmol/l)	Baseline
Secondary	Methylmalonic acid	Methylmalonic acid (µg/l)	Baseline
Secondary	Vitamin B1 status	Vitamin B1 (nmol/l)	Baseline
Secondary	Vitamin B2 status	Vitamin B2 (µg/l)	Baseline
Secondary	Vitamin B6 status	Vitamin B6 (nmol/l)	Baseline
Secondary	Vitamin C status	Vitamin C (mg/l)	Baseline
Secondary	Vitamin D status	Vitamin D (nmol/l)	Baseline
Secondary	Vitamin E status	Vitamin E (µmol/l)	Baseline
Secondary	Iron	Iron (µmol/l)	Baseline
Secondary	Ferritin	Ferritin (µg/l)	Baseline
Secondary	Transferrin	Transferrin (mg/dl)	Baseline
Secondary	Zinc status	Zinc (µg/l)	Baseline
Secondary	Selenium status	Selenium (µg/l)	Baseline
Secondary	Iodine status	Iodine (µg/l)	Baseline
Secondary	Blood pressure	Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg)	Baseline
Secondary	Blood lipids	Total cholesterol, LDL, HDL, triacylglycerides (mmol/l)	Baseline
Secondary	Fasting insulin	Fasting insulin (mU/l)	Baseline
Secondary	Fasting glucose	Fasting glucose (mmol/l)	Baseline
Secondary	Glycated hemoglobin (HbA1c)	HbA1c (%)	Baseline
Secondary	C-peptide	C-peptide (ng/ml)	Baseline
Secondary	Osteocalcin	Osteocalcin (ng/ml)	Baseline
Secondary	Ostase	Ostase (µg/l)	Baseline
Secondary	Parathormone	Parathormone (ng/l)	Baseline
Secondary	N-terminal propeptide of type I procollagen (PINP)	PINP (ng/ml)	Baseline
Secondary	C-terminal telopeptide of type I collagen (CTX)	CTX (ng/ml)	Baseline
Secondary	Creatinine	Creatinine (mmol/24h)	Baseline
Secondary	Uric acid	Uric acid (mg/24h)	Baseline
Secondary	Cytstatin C	Cytstatin C (mg/l)	Baseline
Secondary	Thyroid stimulating hormone (TSH)	TSH (mU/l)	Baseline
Secondary	Free triiodothyronine (fT3)	fT3 (pmol/l)	Baseline
Secondary	Free thyroxine (fT4)	fT4 (pmol/l)	Baseline
Secondary	Body fat	Body fat (kg)	Baseline
Secondary	Skeletal muscle mass	Skeletal muscle mass (kg)	Baseline
Secondary	Total Body Water	Total Body Water (l)	Baseline
Secondary	Energy intake	Calories per day	Baseline
Secondary	Nutrient intake	Milligramm per day	Baseline
Secondary	Intake of dietary supplements	Frequencies per day	Baseline
Secondary	Intake of medication	Frequencies per day	Baseline

External Links

•   summary