Nutritional Biomarker Screening for Defined Food Groups (Challenge)

Screening to Validate and Identify Nutrition-related Biomarkers for Definded Food Groups (Dairy Products, Whole Grain, Processed Meat, Vegetarian Sausage Alternatives)

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).

Study Overview

• Status: Completed
• Conditions: Healthy Lifestyle
• Intervention / Treatment: Dietary supplement: Selected food groups

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).

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Institute of Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Dietary supplement: Selected food groups; Food groups; Milk and dairy products; Whole-grain products (rich in soluble fibers); Sausage and processed meat (pork); Meat-free sausage and meat alternatives (based on egg, soy)
EXPERIMENTAL: 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	Dietary supplement: Selected food groups; Food groups; Milk and dairy products; Whole-grain products (rich in soluble fibers); Sausage and processed meat (pork); Meat-free sausage and meat alternatives (based on egg, soy)
EXPERIMENTAL: 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)	Dietary supplement: Selected food groups; Food groups; Milk and dairy products; Whole-grain products (rich in soluble fibers); Sausage and processed meat (pork); Meat-free sausage and meat alternatives (based on egg, soy)
EXPERIMENTAL: 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)	Dietary supplement: Selected food groups; Food groups; Milk and dairy products; Whole-grain products (rich in soluble fibers); Sausage and processed meat (pork); Meat-free sausage and meat alternatives (based on egg, soy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatty acids, concentration in %fatty acid methyl esters	Fatty acids distribution in plasma lipids, inclusive odd-chain fatty acids	Change from baseline after 5 days of the standardised diet

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-methylhistidineanserine, concentration	Marker for meat consumption	Change from baseline after 5 days of the standardised diet
3-methylhistidineanserine, concentration	Marker for meat consumption	Change from baseline after 5 days of the standardised diet
Asymmetric dimethylarginine, concentration	Marker for meat consumption	Change from baseline after 5 days of the standardised diet
Homoarginine, concentration	Marker for meat consumption	Change from baseline after 5 days of the standardised diet
Trimethylamine N-oxide, concentration	Marker for meat consumption	Change from baseline after 5 days of the standardised diet
Syringol sulfate, concentration	Biomarkers for smoked meat intake	Change from baseline after 5 days of the standardised diet
Alkylresorcinol, concentration	Markers for consumption of whole grains	Change from baseline after 5 days of the standardised diet
Wheat germ agglutinin, concentration	Marker for consumption of whole grains	Change from baseline after 5 days of the standardised diet
Galactitol, concentration	Markers for consumption of dairy products	Change from baseline after 5 days of the standardised diet
Galactonate, concentration	Markers for consumption of dairy products	Change from baseline after 5 days of the standardised diet
Galactono-1,5-lactone, concentration	Markers for consumption of dairy products	Change from baseline after 5 days of the standardised diet
3-phenyllactic acid, concentration	Markers for consumption of dairy products	Change from baseline after 5 days of the standardised diet

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index, kg/m2	Anthropometric data	Change from baseline after 5 days of the standardised diet
Systolic blood pressure, mm Hg	Cardiovascular risk factor	Change from baseline after 5 days of the standardised diet
Diastolic blood pressure, mm Hg	Cardiovascular risk factor	Change from baseline after 5 days of the standardised diet
Total cholesterol, mmol/l	Cardiovascular risk factors	Change from baseline after 5 days of the standardised diet
LDL cholesterol, mmol/l	Cardiovascular risk factors	Change from baseline after 5 days of the standardised diet
HDL cholesterol, mmol/l	Cardiovascular risk factors	Change from baseline after 5 days of the standardised diet
Triacylglcerides, mmol/l	Cardiovascular risk factors	Change from baseline after 5 days of the standardised diet
High sensitive c-reactive protein, mg/l	Inflammation marker	Change from baseline after 5 days of the standardised diet
Fasting glucose, mmol/l	Diabetes risk factor	Change from baseline after 5 days of the standardised diet
Fasting insulin, mU/l	Diabetes risk factor	Change from baseline after 5 days of the standardised diet

Collaborators and Investigators

• Sponsor: University of Jena
• Investigators: Principal Investigator: Christine Dawczynski, PhD, Friedrich-Schiller-University Jena

Publications and helpful links

Helpful Links

• Website of the study center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2021
• Primary Completion (ACTUAL): November 19, 2021
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (ACTUAL): October 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: dairy products, whole grains, sausage, soy
• Other Study ID Numbers: H12_21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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