Nutritional Evaluation - NuEva Study

Nutritional Evaluation Clinical Trial

— NuEva  

Official title:

Nutritional Evaluation - NuEva Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582020
• Other study ID #: H8_18
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: December 21, 2020

Study information

• Verified date: March 2024
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 21, 2020
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Evaluation

Intervention

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

Locations

Country	Name	City	State
Germany	Friedrich-Schiller-University	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anthropometric data	body mass index (kg/m2)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	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)
Secondary	diastolic blood pressure	diastolic blood pressure (mmHg)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	Bioelectrical impedance	bioelectrical impedance	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	Basal metabolic rate (BMR)	basal metabolic rate (BMR)	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	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)
Secondary	vitamin A	vitamin A (mmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	vitamin D	vitamin D (nmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	vitamin E	vitamin E (µmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	vitamin B1	vitamin B1 (nmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	vitamin B6	vitamin B6 (nmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	vitamin B12	vitamin B12 (pmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	folic acid	folic acid (µg/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	calcium	calcium (mmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	iron	iron (µmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	ferritin	ferritin (µg/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	transferin	transferin (g/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	kalium	kalium (mmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	metabolic profiling	Metabolic profiling (186 endogenous metabolites, AbsoluteIDQ p180 Kit from Biocrates)	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	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)
Secondary	apolipoproteins	apolipoprotein AI, B (g/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	homocysteine	homocysteine (µmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	lipoprotein(a)	lipoprotein(a) (mg/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	asymmetric dimethylarginine	asymmetric dimethylarginine, ADMA (µmol/l)	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	homoarginine	homoarginine (µmol/l)	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	trimethylamine N-oxide	trimethylamine N-oxide, TMAO (µmol/l)	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	insulin	insulin (mU/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	HbA1c	HbA1c (%)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	glucose	glucose (mmol/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	alpha prothrombin time	alpha prothrombin time (s)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	fibrinogen	fibrinogen (g/l)	change from baseline after 12, 24, 36 and 48 weeks (optional after 60, 72, 84, 96 weeks)
Secondary	cystatin C	cystatin C (marker for kidney function), mg/l	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	NT-pro-BNP	NT-pro-BNP (marker for cardiac function, volume regulation), pg/ml	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	troponin	troponin (TnT or TnI - marker for myocardial necrosis), pg/ml	change from baseline after 48 weeks (optional after 96 weeks)
Secondary	galectin 3	galectin 3 (marker for fibrosis), ng/ml	change from baseline after 48 weeks (optional after 96 weeks)

External Links

•   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.
•   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
•   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,
•   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.)