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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05067465
Other study ID # H12_21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2021
Est. completion date February 28, 2022

Study information

Verified date February 2023
Source University of Jena
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date February 28, 2022
Est. primary completion date November 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Germany Institute of Nutritional Sciences Jena Thuringia

Sponsors (1)

Lead Sponsor Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Body mass index, kg/m2 Anthropometric data Change from baseline after 5 days of the standardised diet
Other Systolic blood pressure, mm Hg Cardiovascular risk factor Change from baseline after 5 days of the standardised diet
Other Diastolic blood pressure, mm Hg Cardiovascular risk factor Change from baseline after 5 days of the standardised diet
Other Total cholesterol, mmol/l Cardiovascular risk factors Change from baseline after 5 days of the standardised diet
Other LDL cholesterol, mmol/l Cardiovascular risk factors Change from baseline after 5 days of the standardised diet
Other HDL cholesterol, mmol/l Cardiovascular risk factors Change from baseline after 5 days of the standardised diet
Other Triacylglcerides, mmol/l Cardiovascular risk factors Change from baseline after 5 days of the standardised diet
Other High sensitive c-reactive protein, mg/l Inflammation marker Change from baseline after 5 days of the standardised diet
Other Fasting glucose, mmol/l Diabetes risk factor Change from baseline after 5 days of the standardised diet
Other Fasting insulin, mU/l Diabetes risk factor Change from baseline after 5 days of the standardised diet
Primary 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
Secondary 1-methylhistidineanserine, concentration Marker for meat consumption Change from baseline after 5 days of the standardised diet
Secondary 3-methylhistidineanserine, concentration Marker for meat consumption Change from baseline after 5 days of the standardised diet
Secondary Asymmetric dimethylarginine, concentration Marker for meat consumption Change from baseline after 5 days of the standardised diet
Secondary Homoarginine, concentration Marker for meat consumption Change from baseline after 5 days of the standardised diet
Secondary Trimethylamine N-oxide, concentration Marker for meat consumption Change from baseline after 5 days of the standardised diet
Secondary Syringol sulfate, concentration Biomarkers for smoked meat intake Change from baseline after 5 days of the standardised diet
Secondary Alkylresorcinol, concentration Markers for consumption of whole grains Change from baseline after 5 days of the standardised diet
Secondary Wheat germ agglutinin, concentration Marker for consumption of whole grains Change from baseline after 5 days of the standardised diet
Secondary Galactitol, concentration Markers for consumption of dairy products Change from baseline after 5 days of the standardised diet
Secondary Galactonate, concentration Markers for consumption of dairy products Change from baseline after 5 days of the standardised diet
Secondary Galactono-1,5-lactone, concentration Markers for consumption of dairy products Change from baseline after 5 days of the standardised diet
Secondary 3-phenyllactic acid, concentration Markers for consumption of dairy products Change from baseline after 5 days of the standardised diet
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