Nutritional Biomarker Screening for Defined Food Groups

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Healthy Lifestyle

Intervention / Treatment
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* Dietary Supplement: Selected food groups


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Standardized diet over five days (n = 4x40) and test meal on day 6 with postprandial profiling (n = 4x12): Four groups characterized by defined intake of: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Milk and dairy products<br>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<br>* 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)<br>|
| Experimental: Whole-grain products (rich in soluble fibers)<br>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<br>* 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)<br>|
| Experimental: Sausage and processed meat (pork)<br>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<br>* 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)<br>|
| Experimental: Meat-free sausage and meat alternatives (based on egg, pea, soy)<br>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<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dairy products, whole grains, sausage, soy