Nutritional EvaluationNuEvaNCT03582020
Nutritional Evaluation - NuEva Study
A study testing menu plans in people with Nutritional Evaluation, run by University of Jena at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Evaluation
- What is being tested?
- menu plans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jun 2018to 21 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Nutritional Evaluation
- Being tested
- menu plans
- Keywords
- vegetarians, vegans, flexitarians, western diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menu plansDietary supplement
Also called menu plans, recommendations
menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition
| Study group | Role | What they receive |
|---|---|---|
| Traditional Western Diet | Placebo comparator | Intervention: Menu plans and recommendations for persons who consume a traditional Western diet (daily consumption of meat and sausage) Receives: Dietary Supplement: menu plans |
| Flexitarians | Active comparator | Intervention: Menu plans and recommendations for persons, who rarely consume meat and meat products (predominantly high-quality products; ≤ 2 times / week) = flexitarians Receives: Dietary Supplement: menu plans |
| Vegetarians | Active comparator | Intervention: Menu plans and recommendations for persons who do not eat meat and sausage (vegetarians) Receives: Dietary Supplement: menu plans |
| Vegans | Active comparator | Intervention: Menu plans and recommendations for persons who do not eat products from animal origin (vegans) Receives: Dietary Supplement: menu plans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary outcomes (35)
Anthropometric data
body mass index (kg/m2)
Measured: 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)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
diastolic blood pressure
diastolic blood pressure (mmHg)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Bioelectrical impedance
bioelectrical impedance
Measured: 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)
Measured: 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))
Measured: change from baseline after 48 weeks (optional after 96 weeks)
vitamin A
vitamin A (mmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin D
vitamin D (nmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin E
vitamin E (µmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B1
vitamin B1 (nmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B6
vitamin B6 (nmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B12
vitamin B12 (pmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
folic acid
folic acid (µg/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
calcium
calcium (mmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
iron
iron (µmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
ferritin
ferritin (µg/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
transferin
transferin (g/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
kalium
kalium (mmol/l)
Measured: 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)
Measured: change from baseline after 48 weeks (optional after 96 weeks)
high sensitive c-reactive protein
high sensitive c-reactive protein (mg/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
apolipoproteins
apolipoprotein AI, B (g/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
homocysteine
homocysteine (µmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
lipoprotein(a)
lipoprotein(a) (mg/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
asymmetric dimethylarginine
asymmetric dimethylarginine, ADMA (µmol/l)
Measured: change from baseline after 48 weeks (optional after 96 weeks)
homoarginine
homoarginine (µmol/l)
Measured: change from baseline after 48 weeks (optional after 96 weeks)
trimethylamine N-oxide
trimethylamine N-oxide, TMAO (µmol/l)
Measured: change from baseline after 48 weeks (optional after 96 weeks)
insulin
insulin (mU/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
HbA1c
HbA1c (%)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
glucose
glucose (mmol/l)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
alpha prothrombin time
alpha prothrombin time (s)
Measured: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
fibrinogen
fibrinogen (g/l)
Measured: 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
Measured: change from baseline after 48 weeks (optional after 96 weeks)
NT-pro-BNP
NT-pro-BNP (marker for cardiac function, volume regulation), pg/ml
Measured: change from baseline after 48 weeks (optional after 96 weeks)
troponin
troponin (TnT or TnI - marker for myocardial necrosis), pg/ml
Measured: change from baseline after 48 weeks (optional after 96 weeks)
galectin 3
galectin 3 (marker for fibrosis), ng/ml
Measured: change from baseline after 48 weeks (optional after 96 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start4 Jun 2018
- Primary completion16 Dec 2019
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nutritional EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582020
- Sponsor's protocol ID
- H8_18
- Acronym
- NuEva
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2018
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publication of the study data and results in national and international journals
Publications
Lenz C, Seel W, Dombrowski T, Hacker S, Simon M-C, Zentgraf K, Dawczynski C, Kruger K. Signatures in the gut microbiome of German elite athletes: insights from a matched-subgroup analysis. mSystems. 2026 Jul 21;11(7):e0048926. doi: 10.1128/msystems.00489-26. Epub 2026 Jun 30.
PubMed 42377028Klein L, Lenz C, Kruger K, Lorkowski S, Kipp K, Dawczynski C. Comparative analysis of fatty acid profiles across omnivorous, flexitarians, vegetarians, and vegans: insights from the NuEva study. Lipids Health Dis. 2025 Apr 9;24(1):133. doi: 10.1186/s12944-025-02517-6.
PubMed 40205391Dawczynski 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.
PubMed 33604351
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Evaluation - NuEva Study
- ClinicalTrials.gov ID
- NCT03582020
- Acronym / sponsor ID
- NuEva / H8_18
- Conditions
- Nutritional Evaluation
- Keywords
- vegetarians, vegans, flexitarians, western diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Traditional Western Diet | Placebo comparator | Dietary Supplement: menu plansIntervention: Menu plans and recommendations for persons who consume a traditional Western diet (daily consumption of meat and sausage) |
| Flexitarians | Active comparator | Dietary Supplement: menu plansIntervention: Menu plans and recommendations for persons, who rarely consume meat and meat products (predominantly high-quality products; ≤ 2 times / week) = flexitarians |
| Vegetarians | Active comparator | Dietary Supplement: menu plansIntervention: Menu plans and recommendations for persons who do not eat meat and sausage (vegetarians) |
| Vegans | Active comparator | Dietary Supplement: menu plansIntervention: Menu plans and recommendations for persons who do not eat products from animal origin (vegans) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| menu plansAlso: menu plans, recommendationsmenu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition | Dietary supplement | Flexitarians, Traditional Western Diet, Vegans, Vegetarians |
Primary outcome
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
35 secondary outcomes
Anthropometric data
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
systolic blood pressure
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
diastolic blood pressure
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Bioelectrical impedance
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Basal metabolic rate (BMR)
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
Fatty acid distribution in plasma lipids und erythrocyte lipids
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
vitamin A
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin D
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin E
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B1
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B6
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B12
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
folic acid
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
calcium
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
iron
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
ferritin
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
transferin
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
kalium
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
metabolic profiling
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
high sensitive c-reactive protein
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
apolipoproteins
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
homocysteine
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
lipoprotein(a)
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
asymmetric dimethylarginine
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
homoarginine
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
trimethylamine N-oxide
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
insulin
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
HbA1c
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
glucose
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
alpha prothrombin time
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
fibrinogen
Time frame: change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
cystatin C
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
NT-pro-BNP
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
troponin
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
galectin 3
Time frame: change from baseline after 48 weeks (optional after 96 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 42377028Lenz C, Seel W, Dombrowski T, Hacker S, Simon M-C, Zentgraf K, Dawczynski C, Kruger K. Signatures in the gut microbiome of German elite athletes: insights from a matched-subgroup analysis. mSystems. 2026 Jul 21;11(7):e0048926. doi: 10.1128/msystems.00489-26. Epub 2026 Jun 30.
- Derived from this study: PubMed 40205391Klein L, Lenz C, Kruger K, Lorkowski S, Kipp K, Dawczynski C. Comparative analysis of fatty acid profiles across omnivorous, flexitarians, vegetarians, and vegans: insights from the NuEva study. Lipids Health Dis. 2025 Apr 9;24(1):133. doi: 10.1186/s12944-025-02517-6.
- Derived from this study: PubMed 33604351Dawczynski 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.
- Study protocoll (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 and prevention of non-communicable disease - the Nutritional Evaluation (NuEva) study.)Link provided by the sponsor.
- Dawczynski C, Weidauer T, Richert C, Schlattmann P, Dawczynski K, Kiehntopf M. Nutrient intake and nutrition status in vegetarians and vegans in comparison to omnivores - the Nutritional Evaluation (NuEva) study. Frontiers in Nutrition 2022, 9: 819106.Link provided by the sponsor.
- Seel W, Reiners S, Kipp K, Simon M-C, Dawczynski C\*. Role of Dietary Fiber and Energy Intake on Gut Microbiome in Vegans, Vegetarians, and Flexitarians in Comparison to Omnivores-Insights from the Nutritional Evaluation (NuEva) Study. Nutrients 2023, 15,Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. publication of the study data and results in national and international journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing menu plans in people with Nutritional Evaluation, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03582020, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.