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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk and dairy products | Experimental | 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 |
|
| Whole-grain products (rich in soluble fibers) | Experimental | 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 |
|
| Sausage and processed meat (pork) | Experimental | 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) |
|
| Meat-free sausage and meat alternatives (based on egg, pea, soy) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selected food groups | Dietary Supplement | Food groups
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Dawczynski, PhD | Friedrich-Schiller-University Jena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutritional Sciences | Jena | Thuringia | 07743 | Germany |
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| Label | URL |
|---|---|
| Website of the study center | View source |
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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:
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| 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 |
| 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 |