Nutritional Evaluation - NuEva Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- blood lipids after implementation of menu plans
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
blood lipids after implementation of menu plans
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
Secondary Outcomes
- vitamin B12(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- iron(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- kalium(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- lipoprotein(a)(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- diastolic blood pressure(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- vitamin A(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- folic acid(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- transferin(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- homoarginine(change from baseline after 48 weeks (optional after 96 weeks))
- glucose(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- fibrinogen(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- Basal metabolic rate (BMR)(change from baseline after 48 weeks (optional after 96 weeks))
- vitamin D(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- vitamin B1(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- metabolic profiling(change from baseline after 48 weeks (optional after 96 weeks))
- high sensitive c-reactive protein(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- asymmetric dimethylarginine(change from baseline after 48 weeks (optional after 96 weeks))
- cystatin C(change from baseline after 48 weeks (optional after 96 weeks))
- Anthropometric data(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- systolic blood pressure(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- Fatty acid distribution in plasma lipids und erythrocyte lipids(change from baseline after 48 weeks (optional after 96 weeks))
- calcium(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- apolipoproteins(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- homocysteine(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- HbA1c(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- Bioelectrical impedance(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- vitamin E(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- vitamin B6(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- ferritin(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- trimethylamine N-oxide(change from baseline after 48 weeks (optional after 96 weeks))
- insulin(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- alpha prothrombin time(change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks))
- NT-pro-BNP(change from baseline after 48 weeks (optional after 96 weeks))
- troponin(change from baseline after 48 weeks (optional after 96 weeks))
- galectin 3(change from baseline after 48 weeks (optional after 96 weeks))
Investigators
Christine Dawczynski,PhD
Head of Junior Research Group Nutritional Concepts
University of Jena