Clinical Trials Logo

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).

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05067465
Study type Interventional
Source University of Jena
Contact Christine Dawczynski, PhD
Phone +49 3641 949656
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 14, 2021
Completion date February 28, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05019339 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity in SNAP-Education N/A
Completed NCT04555746 - Active Kindergarten - Active Children N/A
Completed NCT01579708 - Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial Phase 3
Not yet recruiting NCT05031377 - Effects of Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of ASCVD N/A
Not yet recruiting NCT04638413 - Cognitive Training Through Gaming and Walking N/A
Completed NCT04675658 - Stay Active Physical Activity Program N/A
Recruiting NCT04571775 - Effects of a Lifestyle Product on Physiological Measures and Subjective Well-being in Humans: A Systematic Study N/A
Recruiting NCT05067816 - Med-South Lifestyle Program Implementation Study N/A
Recruiting NCT05050240 - BATokines as Biomarkers of Brown Fat in Humans N/A
Recruiting NCT04145453 - Vegetables Intake and Polymorphism TAS2R38 Gene by Healthy Adults N/A
Not yet recruiting NCT03996109 - Living Green and Healthy for Teens N/A
Active, not recruiting NCT04823533 - Improving Wellbeing Through the Brain-Gut-Microbiota Axis N/A
Recruiting NCT05021692 - Efficiency of the Web-Based Support Program Based on the Health Promotion Model in Pregnant Women With Preeclampsia N/A
Not yet recruiting NCT04802291 - HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity N/A
Recruiting NCT05002049 - Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project) N/A
Completed NCT04492527 - Student-delivered Telehealth Program for COVID-19 Education and Health Promotion N/A
Active, not recruiting NCT04005495 - Emory Teaching Kitchen Collaborative N/A
Recruiting NCT04453475 - Feasibility and Benefits of Digital Services During the COVID19 Pandemic N/A
Completed NCT04950387 - Impact of Breathing Exercise Intervention on Breathing Sectors Engagement in Adolescent Runners During Load N/A
Terminated NCT04234009 - Lifestyle and Brain Vascular Function N/A