Clinical trial NCT03582020: Nutritional Evaluation - NuEva Study
Official title: Nutritional Evaluation - NuEva Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Evaluation
Keywords: vegetarians
vegans
flexitarians
western diet
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood lipids after implementation of menu plans
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary outcomes:
measure: Anthropometric data
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: systolic blood pressure
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: diastolic blood pressure
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: Bioelectrical impedance
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: Basal metabolic rate (BMR)
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: Fatty acid distribution in plasma lipids und erythrocyte lipids
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: vitamin A
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: vitamin D
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: vitamin E
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: vitamin B1
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: vitamin B6
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: vitamin B12
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: folic acid
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: calcium
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: iron
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: ferritin
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: transferin
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: kalium
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: metabolic profiling
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: high sensitive c-reactive protein
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: apolipoproteins
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: homocysteine
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: lipoprotein(a)
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: asymmetric dimethylarginine
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: homoarginine
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: trimethylamine N-oxide
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: insulin
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: HbA1c
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: glucose
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: alpha prothrombin time
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: fibrinogen
timeFrame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
measure: cystatin C
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: NT-pro-BNP
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: troponin
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
measure: galectin 3
timeFrame: change from baseline after 48 weeks (optional after 96 weeks)
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-University
state: Thuringia
Study officials:
References:
citation: Dawczynski C. A Study Protocol for a Parallel-Designed Trial Evaluating the Impact of Plant-Based Diets in Comparison to Animal-Based Diets on Health Status and Prevention of Non-communicable Diseases-The Nutritional Evaluation (NuEva) Study. Front Nutr. 2021 Feb 2;7:608854. doi: 10.3389/fnut.2020.608854. eCollection 2020.