Friedrich-Schiller-University
Jena, Thuringia, 07743, Germany
NCT Number: NCT03582020
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.
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Notify Me19 year–55 year
All sexes
Interventional
Not applicable
Jena, Thuringia, 07743, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition
Other names: menu plans, recommendations
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
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)
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 (mm Hg)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
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
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
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 (> 90 fatty acids, including SFA, MUFA, PUFA; % fatty acid methyl esters (FAME))
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
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 (nmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
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 (nmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
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 (pmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
folic acid (µg/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
calcium (mmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
iron (µmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
ferritin (µg/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
transferin (g/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
kalium (mmol/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
Metabolic profiling (186 endogenous metabolites, AbsoluteIDQ p180 Kit from Biocrates)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
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)
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 (µmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
lipoprotein(a) (mg/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
asymmetric dimethylarginine, ADMA (µmol/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
homoarginine (µmol/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
trimethylamine N-oxide, TMAO (µmol/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
insulin (mU/l)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
HbA1c (%)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
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 (s)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
fibrinogen (g/l)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
cystatin C (marker for kidney function), mg/l
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
NT-pro-BNP (marker for cardiac function, volume regulation), pg/ml
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
troponin (TnT or TnI - marker for myocardial necrosis), pg/ml
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
galectin 3 (marker for fibrosis), ng/ml
University of Jena
Other
Acronym: NuEva
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