Institute of Nutritional Sciences
Jena, Thuringia, 07743, Germany
NCT Number: NCT05067465
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).
Looking for future studies?
Notify Me20 year–40 year
All sexes
Interventional
Not applicable
Jena, Thuringia, 07743, Germany
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Food groups
Time frame: Change from baseline after 5 days of the standardised diet
Fatty acids distribution in plasma lipids, inclusive odd-chain fatty acids
Time frame: Change from baseline after 5 days of the standardised diet
Marker for meat consumption
Time frame: Change from baseline after 5 days of the standardised diet
Marker for meat consumption
Time frame: Change from baseline after 5 days of the standardised diet
Marker for meat consumption
Time frame: Change from baseline after 5 days of the standardised diet
Marker for meat consumption
Time frame: Change from baseline after 5 days of the standardised diet
Marker for meat consumption
Time frame: Change from baseline after 5 days of the standardised diet
Biomarkers for smoked meat intake
Time frame: Change from baseline after 5 days of the standardised diet
Markers for consumption of whole grains
Time frame: Change from baseline after 5 days of the standardised diet
Marker for consumption of whole grains
Time frame: Change from baseline after 5 days of the standardised diet
Markers for consumption of dairy products
Time frame: Change from baseline after 5 days of the standardised diet
Markers for consumption of dairy products
Time frame: Change from baseline after 5 days of the standardised diet
Markers for consumption of dairy products
Time frame: Change from baseline after 5 days of the standardised diet
Markers for consumption of dairy products
Time frame: Change from baseline after 5 days of the standardised diet
Anthropometric data
Time frame: Change from baseline after 5 days of the standardised diet
Cardiovascular risk factor
Time frame: Change from baseline after 5 days of the standardised diet
Cardiovascular risk factor
Time frame: Change from baseline after 5 days of the standardised diet
Cardiovascular risk factors
Time frame: Change from baseline after 5 days of the standardised diet
Cardiovascular risk factors
Time frame: Change from baseline after 5 days of the standardised diet
Cardiovascular risk factors
Time frame: Change from baseline after 5 days of the standardised diet
Cardiovascular risk factors
Time frame: Change from baseline after 5 days of the standardised diet
Inflammation marker
Time frame: Change from baseline after 5 days of the standardised diet
Diabetes risk factor
Time frame: Change from baseline after 5 days of the standardised diet
Diabetes risk factor
University of Jena
Other
Screening to Validate and Identify Nutrition-related Biomarkers for Definded Food Groups (Dairy Products, Whole Grain, Processed Meat, Vegetarian Sausage Alternatives)
Acronym: Challenge
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07227220
Behavior, Behavior, Health
Houston, Texas, United States
View Trial DetailsNCT06383481
Endocrine System Diseases, Healthy Lifestyle
Erzurum, palandöken, Turkey (Türkiye)
View Trial DetailsNCT04802291
Behavior, Body Weight
New Brunswick, New Jersey, United States
View Trial DetailsNCT05678426
Behavior, Fasting
Hall in Tirol, Tyrol, Austria
View Trial Details