The NuEva study focusses on the development and the validation of nutritional concepts for healthy persons with different dietary habits, such as Western diet, flexitarians, vegetarians, as well as vegans. The practical nutritional concepts will ensure an optimal intake of macro- and micronutrients according to the guidelines of the nutritional societies and contribute to prevention and therapy of civilization disease, such as cardiovascular diseases. In addition, the contribution of the nutritional habits on health and disease status (focus cardiovascular diseases) will be evaluated.
The implementation of the vegetarian and vegan lifestyle is characterized by omitting defined food groups such as meat, sausage (vegetarians) or additionally dairy products and honey (vegans). This bears the risk of undersupply with valuable nutrients. Critical nutrients in the vegetarian-vegan lifestyle are low intakes of vitamin B12, vitamin D, n-3 LC-PUFA, calcium, iron, zinc as well as a high phytate intake. The hype of the vegetarian and vegan lifestyle in combination with hints for critical nutrients following the adoption to these eating habits highlights the need of a comprehensive data collection that allows for making recommendations based on reliable scientific evidence. To address this need, the proposed NuEva study will enroll 55 vegetarians (adherence of at least 1 year), 55 vegans (adherence of at least 1 year), as well as 55 flexitarians (characteristics: selected and rare meat/sausage consumption, once or twice per week, adherence of at least 1 year). Further, 55 participants who consume a Western diet (adherence of at least 1 year) will be recruited as control group). Run-in/screening To record and document the varieties in dietary practices within and among each group, the 14 d run-in phase of the proposed study will include individual assessments of dietary habits using self-reports (FFPs, lifestyle questionnaires). Screening (sampling): comprehensive nutrient analyses (vitamins, minerals, trace elements) in plasma/serum samples Intervention Based on the screening data, critical nutrients will be identified for each participant and summarized for each group. Based on these data and published scientific data, defined nutrition plans and recommendations ensuring adequate nutrient intake will be developed for each group (according to the guidelines of the German Society of Nutrition (DGE)). The plans are adapted to individual energy requirements based on basal metabolic rate (BMR) and physical activity (PAL) of each study participant. The compliance with the menu plans and the physiological impact on health and disease status will be controlled by analyzing nutrient status in blood samples, which are complemented by metabolomic profiling every 6 months. In addition, a regularly health check and nutritional counselling in combination with the analysis of blood lipids and nutrition status are planned every 3 months. Optionally, we are interested to investigate the relationships between the different dietary habits and the participants' microbiomes. Therefore, collection of feces samples every 12 month is envisaged.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition
Friedrich-Schiller-University
Jena, Thuringia, Germany
blood lipids after implementation of menu plans
LDL/HDL ratio and blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides in mmol/l) after implementation of menu plans
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Anthropometric data
body mass index (kg/m2)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
systolic blood pressure
systolic blood pressure (mm Hg)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
diastolic blood pressure
diastolic blood pressure (mmHg)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Bioelectrical impedance
bioelectrical impedance
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Basal metabolic rate (BMR)
basal metabolic rate (BMR)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
Fatty acid distribution in plasma lipids und erythrocyte lipids
Fatty acid distribution in plasma lipids und erythrocyte lipids (\> 90 fatty acids, including SFA, MUFA, PUFA; % fatty acid methyl esters (FAME))
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
vitamin A
vitamin A (mmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin D
vitamin D (nmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin E
vitamin E (µmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B1
vitamin B1 (nmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B6
vitamin B6 (nmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B12
vitamin B12 (pmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
folic acid
folic acid (µg/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
calcium
calcium (mmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
iron
iron (µmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
ferritin
ferritin (µg/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
transferin
transferin (g/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
kalium
kalium (mmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
metabolic profiling
Metabolic profiling (186 endogenous metabolites, AbsoluteIDQ p180 Kit from Biocrates)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
high sensitive c-reactive protein
high sensitive c-reactive protein (mg/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
apolipoproteins
apolipoprotein AI, B (g/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
homocysteine
homocysteine (µmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
lipoprotein(a)
lipoprotein(a) (mg/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
asymmetric dimethylarginine
asymmetric dimethylarginine, ADMA (µmol/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
homoarginine
homoarginine (µmol/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
trimethylamine N-oxide
trimethylamine N-oxide, TMAO (µmol/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
insulin
insulin (mU/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
HbA1c
HbA1c (%)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
glucose
glucose (mmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
alpha prothrombin time
alpha prothrombin time (s)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
fibrinogen
fibrinogen (g/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
cystatin C
cystatin C (marker for kidney function), mg/l
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
NT-pro-BNP
NT-pro-BNP (marker for cardiac function, volume regulation), pg/ml
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
troponin
troponin (TnT or TnI - marker for myocardial necrosis), pg/ml
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
galectin 3
galectin 3 (marker for fibrosis), ng/ml
Time frame: change from baseline after 48 weeks (optional after 96 weeks)