Nutritional Evaluation - NuEva Study (NuEva)

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.

Study Overview

• Status: Completed
• Conditions: Nutritional Evaluation
• Intervention / Treatment: Dietary supplement: menu plans

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Friedrich-Schiller-University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Traditional Western Diet; Intervention: Menu plans and recommendations for persons who consume a traditional Western diet (daily consumption of meat and sausage)	Dietary supplement: menu plans; menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition; Other Names: menu plans, recommendations
Active Comparator: Flexitarians; Intervention: Menu plans and recommendations for persons, who rarely consume meat and meat products (predominantly high-quality products; ≤ 2 times / week) = flexitarians	Dietary supplement: menu plans; menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition; Other Names: menu plans, recommendations
Active Comparator: Vegetarians; Intervention: Menu plans and recommendations for persons who do not eat meat and sausage (vegetarians)	Dietary supplement: menu plans; menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition; Other Names: menu plans, recommendations
Active Comparator: Vegans; Intervention: Menu plans and recommendations for persons who do not eat products from animal origin (vegans)	Dietary supplement: menu plans; menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition; Other Names: menu plans, recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric data	body mass index (kg/m2)	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)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
diastolic blood pressure	diastolic blood pressure (mmHg)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Bioelectrical impedance	bioelectrical impedance	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)	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))	change from baseline after 48 weeks (optional after 96 weeks)
vitamin A	vitamin A (mmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin D	vitamin D (nmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin E	vitamin E (µmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B1	vitamin B1 (nmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B6	vitamin B6 (nmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
vitamin B12	vitamin B12 (pmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
folic acid	folic acid (µg/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
calcium	calcium (mmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
iron	iron (µmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
ferritin	ferritin (µg/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
transferin	transferin (g/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
kalium	kalium (mmol/l)	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)	change from baseline after 48 weeks (optional after 96 weeks)
high sensitive c-reactive protein	high sensitive c-reactive protein (mg/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
apolipoproteins	apolipoprotein AI, B (g/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
homocysteine	homocysteine (µmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
lipoprotein(a)	lipoprotein(a) (mg/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
asymmetric dimethylarginine	asymmetric dimethylarginine, ADMA (µmol/l)	change from baseline after 48 weeks (optional after 96 weeks)
homoarginine	homoarginine (µmol/l)	change from baseline after 48 weeks (optional after 96 weeks)
trimethylamine N-oxide	trimethylamine N-oxide, TMAO (µmol/l)	change from baseline after 48 weeks (optional after 96 weeks)
insulin	insulin (mU/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
HbA1c	HbA1c (%)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
glucose	glucose (mmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
alpha prothrombin time	alpha prothrombin time (s)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
fibrinogen	fibrinogen (g/l)	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	change from baseline after 48 weeks (optional after 96 weeks)
NT-pro-BNP	NT-pro-BNP (marker for cardiac function, volume regulation), pg/ml	change from baseline after 48 weeks (optional after 96 weeks)
troponin	troponin (TnT or TnI - marker for myocardial necrosis), pg/ml	change from baseline after 48 weeks (optional after 96 weeks)
galectin 3	galectin 3 (marker for fibrosis), ng/ml	change from baseline after 48 weeks (optional after 96 weeks)

Collaborators and Investigators

• Sponsor: University of Jena

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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.)
• 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.
• 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,
• Klein L, Dawczynski C, Schwarz M, Maares M, Kipp K, Haase H, Kipp AP. Selenium, Zinc, and Copper Status of Vegetarians and Vegans in Comparison to Omnivores in the Nutritional Evaluation (NuEva) Study. Nutrients 2023, 15, 3538

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: western diet; vegetarians; vegans; flexitarians
• Other Study ID Numbers: H8_18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: publication of the study data and results in national and international journals
• IPD Sharing Time Frame: 2021 / 2022
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No