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Completed

NCT Number: NCT05067465

Nutritional Biomarker Screening for Defined Food Groups

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).

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutritional Sciences

Jena, Thuringia, 07743, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selected food groups

Dietary Supplement

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)

Primary outcomes

  1. Fatty acids, concentration in %fatty acid methyl esters

    Time frame: Change from baseline after 5 days of the standardised diet

    Fatty acids distribution in plasma lipids, inclusive odd-chain fatty acids

Secondary outcomes

  1. 1-methylhistidineanserine, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Marker for meat consumption

  2. 3-methylhistidineanserine, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Marker for meat consumption

  3. Asymmetric dimethylarginine, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Marker for meat consumption

  4. Homoarginine, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Marker for meat consumption

  5. Trimethylamine N-oxide, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Marker for meat consumption

  6. Syringol sulfate, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Biomarkers for smoked meat intake

  7. Alkylresorcinol, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Markers for consumption of whole grains

  8. Wheat germ agglutinin, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Marker for consumption of whole grains

  9. Galactitol, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Markers for consumption of dairy products

  10. Galactonate, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Markers for consumption of dairy products

  11. Galactono-1,5-lactone, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Markers for consumption of dairy products

  12. 3-phenyllactic acid, concentration

    Time frame: Change from baseline after 5 days of the standardised diet

    Markers for consumption of dairy products

Other outcomes

  1. Body mass index, kg/m2

    Time frame: Change from baseline after 5 days of the standardised diet

    Anthropometric data

  2. Systolic blood pressure, mm Hg

    Time frame: Change from baseline after 5 days of the standardised diet

    Cardiovascular risk factor

  3. Diastolic blood pressure, mm Hg

    Time frame: Change from baseline after 5 days of the standardised diet

    Cardiovascular risk factor

  4. Total cholesterol, mmol/l

    Time frame: Change from baseline after 5 days of the standardised diet

    Cardiovascular risk factors

  5. LDL cholesterol, mmol/l

    Time frame: Change from baseline after 5 days of the standardised diet

    Cardiovascular risk factors

  6. HDL cholesterol, mmol/l

    Time frame: Change from baseline after 5 days of the standardised diet

    Cardiovascular risk factors

  7. Triacylglcerides, mmol/l

    Time frame: Change from baseline after 5 days of the standardised diet

    Cardiovascular risk factors

  8. High sensitive c-reactive protein, mg/l

    Time frame: Change from baseline after 5 days of the standardised diet

    Inflammation marker

  9. Fasting glucose, mmol/l

    Time frame: Change from baseline after 5 days of the standardised diet

    Diabetes risk factor

  10. Fasting insulin, mU/l

    Time frame: Change from baseline after 5 days of the standardised diet

    Diabetes risk factor

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Acronym: Challenge

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 5, 2021
Registry last updated
Feb 6, 2023

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.

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