Nutritional Biomarker Screening for Defined Food Groups

NCT ID: NCT05067465

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-14
• Study Completion Date: 2022-02-28

Brief Summary

The Biomarker study will be conducted (i) to establish biomarker profiles that reflect the daily diet and regularly dietary habits, (ii) to complement self-reported dietary habits and (iii) to reduce gaps between self-reported information and real dietary intake. The study aims to assess relationships between defined nutrient intake (four groups: 1. Milk and dairy products, 2. Whole-grain products (rich in soluble fibers), 3. Sausage and processed meat (pork), 4. Meat-free sausage and meat alternatives (based on egg, soy) and resulting biochemical markers in human samples (plasma, serum, 24 h urine). In a next step, we will focus on unraveling the connection of the established diet-related metabolites with biomarkers of health and disease status, with focus on cardiovascular diseases (CVD).

Detailed Description

Within the scope of the present study, biomarkers or biomarker profiles are to be identified which reflect the daily diet and eating habits (focus: mixed diet / Western diet, vegetarians, vegans) in order to supplement or complete the information from diet protocols.

The chosen study design enables relationships between a defined nutrient intake in the form of a standardized diet over five days (four groups with 40 subjects each; group 1: Milk and dairy products, group 2: Whole grain products (rich in soluble fiber), group 3: Sausage and processed meat (pork), group 4: Meat-free sausage and meat alternatives (based on egg, soy) and the resulting biochemical markers in the human samples (plasma, serum, whole blood, 24-hour urine).

In addition, one subgroup (n = 12) consumed a test meal with the study foods on day 6 after the 5-day standardized diet. Before the test meal (time 0) and at intervals of 30, 60, 120, 180 min, blood samples are taken (postprandial profiling) in order to examine the brief increase in nutrients from the study foods in the human samples.

The aim of the study is i) to validate already established biomarkers and ii) to identify new biomarkers / patterns.

In the further course of the study, the identified and validated nutrition-associated biomarkers are to be linked to parameters of the health and disease status, whereby in particular the connection to cardiovascular risk factors and endpoints is considered.

Furthermore, the study design enables an assessment of the physiological effects as a result of an increased intake of the selected food (groups).

Conditions

Healthy Lifestyle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Milk and dairy products

Standardized diet over five days (n = 40) - composed of cow milk, cheese, cream cheese, cream, valess milk schnitzel

Test meal on day 6 (n = 12) - composed of milk, cheese, cream cheese, cream

Group Type: EXPERIMENTAL

Selected food groups

Intervention Type: DIETARY_SUPPLEMENT

Food groups

1. Milk and dairy products

2. Whole-grain products (rich in soluble fibers)

3. Sausage and processed meat (pork)

4. Meat-free sausage and meat alternatives (based on egg, soy)

Whole-grain products (rich in soluble fibers)

Standardized diet over five days (n = 40) - composed of oatmeal, oat bran, oat milk, whole wheat pasta, whole wheat bread, hummus

Test meal on day 6 (n = 12) - composed of oatmeal, oat bran, oat milk

Group Type: EXPERIMENTAL

Selected food groups

Intervention Type: DIETARY_SUPPLEMENT

Food groups

1. Milk and dairy products

2. Whole-grain products (rich in soluble fibers)

3. Sausage and processed meat (pork)

4. Meat-free sausage and meat alternatives (based on egg, soy)

Sausage and processed meat (pork)

Standardized diet over five days (n = 40) - composed of Lyoner (pig), Viennese (pig), minced meat (pig)

Test meal on day 6 (n = 12) - composed of Lyoner (pig), Viennese (pig)

Group Type: EXPERIMENTAL

Selected food groups

Intervention Type: DIETARY_SUPPLEMENT

Food groups

1. Milk and dairy products

2. Whole-grain products (rich in soluble fibers)

3. Sausage and processed meat (pork)

4. Meat-free sausage and meat alternatives (based on egg, soy)

Meat-free sausage and meat alternatives (based on egg, pea, soy)

Standardized diet over five days (n = 40) - composed of Mortadella (egg-based), Viennese (egg-based), vegan mince (soy-based)

Test meal on day 6 (n = 12) - composed of Mortadella (egg-based), Viennese (egg-based)

Group Type: EXPERIMENTAL

Selected food groups

Intervention Type: DIETARY_SUPPLEMENT

Food groups

1. Milk and dairy products

2. Whole-grain products (rich in soluble fibers)

3. Sausage and processed meat (pork)

4. Meat-free sausage and meat alternatives (based on egg, soy)

Interventions

Selected food groups

Food groups

1. Milk and dairy products

2. Whole-grain products (rich in soluble fibers)

3. Sausage and processed meat (pork)

4. Meat-free sausage and meat alternatives (based on egg, soy)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Females (before menopause) and males
• Age: 20 < 40 years
• BMI ≥ 18 < 25 kg/m2
• Participants must be subjectively healthy
• Compatibility to one of the four planned groups as confirmed by lifestyle and nutrition-related questionnaires plus food frequency protocol (FFP) over five days
• Precondition: stable eating habits at least one year before enrollment

Exclusion Criteria

• Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, dia-betes mellitus (type I, II), chronic renal disease, diseases of the parathyroid, 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Christine Dawczynski,PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Dawczynski, PhD

Role: PRINCIPAL_INVESTIGATOR

Friedrich-Schiller-University Jena

Locations

Institute of Nutritional Sciences

Jena, Thuringia, Germany

Countries

Germany

Related Links

https://www.nuco.uni-jena.de/studien

Website of the study center

Other Identifiers

H12_21

Identifier Type: -

Identifier Source: org_study_id