NCT03582020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

June 5, 2018

Last Update Submit

March 14, 2024

Conditions

Nutritional Evaluation

Keywords

vegetariansvegansflexitarianswestern diet

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (35)

  • Anthropometric data

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

  • systolic blood pressure

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

  • diastolic blood pressure

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

  • Bioelectrical impedance

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

  • Basal metabolic rate (BMR)

    change from baseline after 48 weeks (optional after 96 weeks)

  • +30 more secondary outcomes

Study Arms (4)

Traditional Western Diet

PLACEBO COMPARATOR

Intervention: Menu plans and recommendations for persons who consume a traditional Western diet (daily consumption of meat and sausage)

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

Dietary Supplement: menu plans

Vegetarians

ACTIVE COMPARATOR

Intervention: Menu plans and recommendations for persons who do not eat meat and sausage (vegetarians)

Dietary Supplement: menu plans

Vegans

ACTIVE COMPARATOR

Intervention: Menu plans and recommendations for persons who do not eat products from animal origin (vegans)

Dietary Supplement: menu plans

Interventions

menu plansDIETARY_SUPPLEMENT

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

Also known as: menu plans, recommendations
FlexitariansTraditional Western DietVegansVegetarians

Eligibility Criteria

Age19 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsfemale (before menopause) and male gender (50 % each)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich-Schiller-University

Jena, Thuringia, 07743, Germany

Location

Related Publications (2)

  • Klein 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.

    PMID: 40205391DERIVED

  • 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.

    PMID: 33604351DERIVED

Related Links

MeSH Terms

Interventions

Menu Planning

Intervention Hierarchy (Ancestors)

Food ServicesFood IndustryIndustryTechnology, Industry, and AgricultureFood Service, HospitalDietary ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Junior Research Group Nutritional Concepts

Study Record Dates

First Submitted

June 5, 2018

First Posted

July 10, 2018

Study Start

June 4, 2018

Primary Completion

December 16, 2019

Study Completion

December 21, 2020

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

publication of the study data and results in national and international journals

Shared Documents
STUDY PROTOCOL
Time Frame
2021 / 2022
More information

Locations

DE(1)