Nutritional Biomarker Screening for Defined Food Groups
Condition: Healthy Lifestyle
Study type: Interventional

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).
    

Intervention name(s): Selected food groups
Intervention type(s): Dietary Supplement
Intervention description(s): 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)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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:
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)
Primary purpose: Treatment
Keywords: dairy products, whole grains, sausage, soy