Nutritional Evaluation - NuEva Study
Condition: Nutritional Evaluation
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): menu plans
Intervention type(s): Dietary Supplement
Intervention description(s): menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition
Other intervention name(s): menu plans, recommendations
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: vegetarians; vegans; flexitarians; western diet