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Completed

NCT Number: NCT03582020

Nutritional Evaluation - NuEva Study

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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Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

menu plans

Dietary Supplement

menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition

Other names: menu plans, recommendations

Primary outcomes

  1. 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

  1. Anthropometric data

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    body mass index (kg/m2)

  2. systolic blood pressure

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    systolic blood pressure (mm Hg)

  3. diastolic blood pressure

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    diastolic blood pressure (mmHg)

  4. Bioelectrical impedance

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    bioelectrical impedance

  5. Basal metabolic rate (BMR)

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    basal metabolic rate (BMR)

  6. Fatty acid distribution in plasma lipids und erythrocyte lipids

    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))

  7. vitamin A

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    vitamin A (mmol/l)

  8. vitamin D

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    vitamin D (nmol/l)

  9. vitamin E

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    vitamin E (µmol/l)

  10. vitamin B1

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    vitamin B1 (nmol/l)

  11. vitamin B6

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    vitamin B6 (nmol/l)

  12. vitamin B12

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    vitamin B12 (pmol/l)

  13. folic acid

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    folic acid (µg/l)

  14. calcium

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    calcium (mmol/l)

  15. iron

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    iron (µmol/l)

  16. ferritin

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    ferritin (µg/l)

  17. transferin

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    transferin (g/l)

  18. kalium

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    kalium (mmol/l)

  19. metabolic profiling

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    Metabolic profiling (186 endogenous metabolites, AbsoluteIDQ p180 Kit from Biocrates)

  20. high sensitive c-reactive protein

    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)

  21. apolipoproteins

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    apolipoprotein AI, B (g/l)

  22. homocysteine

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    homocysteine (µmol/l)

  23. lipoprotein(a)

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    lipoprotein(a) (mg/l)

  24. asymmetric dimethylarginine

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    asymmetric dimethylarginine, ADMA (µmol/l)

  25. homoarginine

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    homoarginine (µmol/l)

  26. trimethylamine N-oxide

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    trimethylamine N-oxide, TMAO (µmol/l)

  27. insulin

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    insulin (mU/l)

  28. HbA1c

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    HbA1c (%)

  29. glucose

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    glucose (mmol/l)

  30. alpha prothrombin time

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    alpha prothrombin time (s)

  31. fibrinogen

    Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

    fibrinogen (g/l)

  32. cystatin C

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    cystatin C (marker for kidney function), mg/l

  33. NT-pro-BNP

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    NT-pro-BNP (marker for cardiac function, volume regulation), pg/ml

  34. troponin

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    troponin (TnT or TnI - marker for myocardial necrosis), pg/ml

  35. galectin 3

    Time frame: change from baseline after 48 weeks (optional after 96 weeks)

    galectin 3 (marker for fibrosis), ng/ml

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Acronym: NuEva

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 10, 2018
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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