Nutritional Biomarker Screening for Defined Food Groups — Challenge  

Healthy Lifestyle Clinical Trial

Official title: Screening to Validate and Identify Nutrition-related Biomarkers for Definded Food Groups (Dairy Products, Whole Grain, Processed Meat, Vegetarian Sausage Alternatives)

Status Completed

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). ;

Related Conditions & MeSH terms

• Healthy Lifestyle

• NCT number: NCT05067465
• Study type: Interventional
• Source: University of Jena
• Status: Completed
• Phase: N/A
• Start date: October 14, 2021
• Completion date: February 28, 2022