Nutritional Biomarker Screening for Defined Food Groups

Healthy Lifestyle Clinical Trial

— Challenge  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05067465
• Other study ID #: H12_21
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Healthy Lifestyle

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

External Links

•   Website of the study center