Nutritional Evaluation - NuEva Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nutritional Evaluation - NuEva Study

Conditions
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Nutritional Evaluation

Intervention / Treatment
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* Dietary Supplement: menu plans


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI < 30 kg/m2 Participants must be subjectively healthy Adherence to one of the four groups (Western diet, flexitarians, vegetarians, vegans) confirmed by lifestyle and nutrition questionnaires, food frequency protocol (7 d) Precondition: stable eating habits for at least two years before enrollment Exclusion Criteria: Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, diabetes mellitus (type I, II), chronic renal disease, diseases of the parathyroids, diseases necessitating regular phlebotomies Intake of additional dietary supplements (e.g. fish oil capsules, vitamins, minerals etc.) Weight loss or weight gain (> 3 kg) during the last three months before study begin Pregnancy or lactation Transfusion of blood in the last three months before blood sample taking

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group design (4 groups), non-randomized Run in (14 d): Food frequency protocol (FFP, 7 d), questionnaires for lifestyle/nutrition/socio-economic status Screening: Fasting blood sample taking, health check Intervention: Four groups differing in their eating habits (pre-condition: stable since at least one year) Intervention - group A: Menu plans for persons who consume a traditional Western diet Intervention - group B: Menu plans for persons who rarely consume meat and meat products (predominantly high-quality products; ≤ 2 times / week) = flexitarians Intervention - group C: Menu plans for vegetarians Intervention - group D: Menu plans for vegans
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Traditional Western Diet<br>Intervention: Menu plans and recommendations for persons who consume a traditional Western diet (daily consumption of meat and sausage) | Dietary Supplement: menu plans<br>* menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition<br>* Other names: menu plans, recommendations;|
| Active Comparator: Flexitarians<br>Intervention: Menu plans and recommendations for persons, who rarely consume meat and meat products (predominantly high-quality products; ≤ 2 times / week) = flexitarians | Dietary Supplement: menu plans<br>* menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition<br>* Other names: menu plans, recommendations;|
| Active Comparator: Vegetarians<br>Intervention: Menu plans and recommendations for persons who do not eat meat and sausage (vegetarians) | Dietary Supplement: menu plans<br>* menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition<br>* Other names: menu plans, recommendations;|
| Active Comparator: Vegans<br>Intervention: Menu plans and recommendations for persons who do not eat products from animal origin (vegans) | Dietary Supplement: menu plans<br>* menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition<br>* Other names: menu plans, recommendations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric data | body mass index (kg/m2) | 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) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| diastolic blood pressure | diastolic blood pressure (mmHg) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| Bioelectrical impedance | bioelectrical impedance | 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) | 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)) | change from baseline after 48 weeks (optional after 96 weeks) | 
| vitamin A | vitamin A (mmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| vitamin D | vitamin D (nmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| vitamin E | vitamin E (µmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| vitamin B1 | vitamin B1 (nmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| vitamin B6 | vitamin B6 (nmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| vitamin B12 | vitamin B12 (pmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| folic acid | folic acid (µg/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| calcium | calcium (mmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| iron | iron (µmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| ferritin | ferritin (µg/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| transferin | transferin (g/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| kalium | kalium (mmol/l) | 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) | change from baseline after 48 weeks (optional after 96 weeks) | 
| high sensitive c-reactive protein | high sensitive c-reactive protein (mg/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| apolipoproteins | apolipoprotein AI, B (g/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| homocysteine | homocysteine (µmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| lipoprotein(a) | lipoprotein(a) (mg/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| asymmetric dimethylarginine | asymmetric dimethylarginine, ADMA (µmol/l) | change from baseline after 48 weeks (optional after 96 weeks) | 
| homoarginine | homoarginine (µmol/l) | change from baseline after 48 weeks (optional after 96 weeks) | 
| trimethylamine N-oxide | trimethylamine N-oxide, TMAO (µmol/l) | change from baseline after 48 weeks (optional after 96 weeks) | 
| insulin | insulin (mU/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| HbA1c | HbA1c (%) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| glucose | glucose (mmol/l) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| alpha prothrombin time | alpha prothrombin time (s) | change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks) | 
| fibrinogen | fibrinogen (g/l) | 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 | change from baseline after 48 weeks (optional after 96 weeks) | 
| NT-pro-BNP | NT-pro-BNP (marker for cardiac function, volume regulation), pg/ml | change from baseline after 48 weeks (optional after 96 weeks) | 
| troponin | troponin (TnT or TnI - marker for myocardial necrosis), pg/ml | change from baseline after 48 weeks (optional after 96 weeks) | 
| galectin 3 | galectin 3 (marker for fibrosis), ng/ml | change from baseline after 48 weeks (optional after 96 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vegetarians, vegans, flexitarians, western diet