Healthy Lifestyle
Conditions
Keywords
dairy products, whole grains, sausage, soy
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).
Interventions
DIETARY_SUPPLEMENTSelected 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)
Sponsors
University of Jena
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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: 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)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 1-methylhistidineanserine, concentration | Change from baseline after 5 days of the standardised diet | Marker for meat consumption |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Systolic blood pressure, mm Hg | Change from baseline after 5 days of the standardised diet | Cardiovascular risk factor |
| Body mass index, kg/m2 | Change from baseline after 5 days of the standardised diet | Anthropometric data |
Countries
Germany
Outcome results
None listed