Challenge: Nutritional Biomarker Screening for Definded Food Groups
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- Fatty acids, concentration in %fatty acid methyl esters [Change from baseline after 5 days of the standardised diet]
Fatty acids distribution in plasma lipids, inclusive odd-chain fatty acids
Secondary Outcome Measures
- 1-methylhistidineanserine, concentration [Change from baseline after 5 days of the standardised diet]
Marker for meat consumption
- 3-methylhistidineanserine, concentration [Change from baseline after 5 days of the standardised diet]
Marker for meat consumption
- Asymmetric dimethylarginine, concentration [Change from baseline after 5 days of the standardised diet]
Marker for meat consumption
- Homoarginine, concentration [Change from baseline after 5 days of the standardised diet]
Marker for meat consumption
- Trimethylamine N-oxide, concentration [Change from baseline after 5 days of the standardised diet]
Marker for meat consumption
- Syringol sulfate, concentration [Change from baseline after 5 days of the standardised diet]
Biomarkers for smoked meat intake
- Alkylresorcinol, concentration [Change from baseline after 5 days of the standardised diet]
Markers for consumption of whole grains
- Wheat germ agglutinin, concentration [Change from baseline after 5 days of the standardised diet]
Marker for consumption of whole grains
- Galactitol, concentration [Change from baseline after 5 days of the standardised diet]
Markers for consumption of dairy products
- Galactonate, concentration [Change from baseline after 5 days of the standardised diet]
Markers for consumption of dairy products
- Galactono-1,5-lactone, concentration [Change from baseline after 5 days of the standardised diet]
Markers for consumption of dairy products
- 3-phenyllactic acid, concentration [Change from baseline after 5 days of the standardised diet]
Markers for consumption of dairy products
Other Outcome Measures
- Body mass index, kg/m2 [Change from baseline after 5 days of the standardised diet]
Anthropometric data
- Systolic blood pressure, mm Hg [Change from baseline after 5 days of the standardised diet]
Cardiovascular risk factor
- Diastolic blood pressure, mm Hg [Change from baseline after 5 days of the standardised diet]
Cardiovascular risk factor
- Total cholesterol, mmol/l [Change from baseline after 5 days of the standardised diet]
Cardiovascular risk factors
- LDL cholesterol, mmol/l [Change from baseline after 5 days of the standardised diet]
Cardiovascular risk factors
- HDL cholesterol, mmol/l [Change from baseline after 5 days of the standardised diet]
Cardiovascular risk factors
- Triacylglcerides, mmol/l [Change from baseline after 5 days of the standardised diet]
Cardiovascular risk factors
- High sensitive c-reactive protein, mg/l [Change from baseline after 5 days of the standardised diet]
Inflammation marker
- Fasting glucose, mmol/l [Change from baseline after 5 days of the standardised diet]
Diabetes risk factor
- Fasting insulin, mU/l [Change from baseline after 5 days of the standardised diet]
Diabetes risk factor
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Nutritional Sciences | Jena | Thuringia | Germany | 07743 |
Sponsors and Collaborators
- University of Jena
Investigators
- Principal Investigator: Christine Dawczynski, PhD, Friedrich-Schiller-University Jena
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- H12_21