Clinical trial NCT05067465: Nutritional Biomarker Screening for Defined Food Groups
Official title: Screening to Validate and Identify Nutrition-related Biomarkers for Definded Food Groups (Dairy Products, Whole Grain, Processed Meat, Vegetarian Sausage Alternatives)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Keywords: dairy products, whole grains, sausage, soy
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Fatty acids, concentration in %fatty acid methyl esters
timeFrame: Change from baseline after 5 days of the standardised diet
Secondary outcomes:
measure: 1-methylhistidineanserine, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: 3-methylhistidineanserine, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Asymmetric dimethylarginine, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Homoarginine, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Trimethylamine N-oxide, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Syringol sulfate, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Alkylresorcinol, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Wheat germ agglutinin, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Galactitol, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Galactonate, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Galactono-1,5-lactone, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
measure: 3-phenyllactic acid, concentration
timeFrame: Change from baseline after 5 days of the standardised diet
Other outcomes:
measure: Body mass index, kg/m2
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Systolic blood pressure, mm Hg
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Diastolic blood pressure, mm Hg
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Total cholesterol, mmol/l
timeFrame: Change from baseline after 5 days of the standardised diet
measure: LDL cholesterol, mmol/l
timeFrame: Change from baseline after 5 days of the standardised diet
measure: HDL cholesterol, mmol/l
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Triacylglcerides, mmol/l
timeFrame: Change from baseline after 5 days of the standardised diet
measure: High sensitive c-reactive protein, mg/l
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Fasting glucose, mmol/l
timeFrame: Change from baseline after 5 days of the standardised diet
measure: Fasting insulin, mU/l
timeFrame: Change from baseline after 5 days of the standardised diet
Locations:
city: Jena
country: Germany
facility: Institute of Nutritional Sciences
state: Thuringia
Study officials:
affiliation: Friedrich-Schiller-University Jena
name: Christine Dawczynski, PhD
role: PRINCIPAL_INVESTIGATOR
References: