Healthy LifestyleChallengeNCT05067465
Nutritional Biomarker Screening for Defined Food Groups
A study testing Selected food groups in people with Healthy Lifestyle, run by University of Jena at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Selected food groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 14 Oct 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening to Validate and Identify Nutrition-related Biomarkers for Definded Food Groups (Dairy Products, Whole Grain, Processed Meat, Vegetarian Sausage Alternatives)
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).
Read the detailed 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).
- Conditions
- Healthy Lifestyle
- Being tested
- Selected food groups
- Keywords
- dairy products, whole grains, sausage, soy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected food groupsDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| Milk and dairy products | Experimental | Standardized diet over five days (n = 40) - composed of cow milk, cheese, cream cheese, cream, valess milk schnitzel
Test meal on day 6 (n = 12) - composed of milk, cheese, cream cheese, cream Receives: Dietary Supplement: Selected food groups |
| Whole-grain products (rich in soluble fibers) | Experimental | Standardized diet over five days (n = 40) - composed of oatmeal, oat bran, oat milk, whole wheat pasta, whole wheat bread, hummus
Test meal on day 6 (n = 12) - composed of oatmeal, oat bran, oat milk Receives: Dietary Supplement: Selected food groups |
| Sausage and processed meat (pork) | Experimental | Standardized diet over five days (n = 40) - composed of Lyoner (pig), Viennese (pig), minced meat (pig)
Test meal on day 6 (n = 12) - composed of Lyoner (pig), Viennese (pig) Receives: Dietary Supplement: Selected food groups |
| Meat-free sausage and meat alternatives (based on egg, pea, soy) | Experimental | Standardized diet over five days (n = 40) - composed of Mortadella (egg-based), Viennese (egg-based), vegan mince (soy-based)
Test meal on day 6 (n = 12) - composed of Mortadella (egg-based), Viennese (egg-based) Receives: Dietary Supplement: Selected food groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acids, concentration in %fatty acid methyl esters
Fatty acids distribution in plasma lipids, inclusive odd-chain fatty acids
Measured: Change from baseline after 5 days of the standardised diet
Secondary outcomes (12)
1-methylhistidineanserine, concentration
Marker for meat consumption
Measured: Change from baseline after 5 days of the standardised diet
3-methylhistidineanserine, concentration
Marker for meat consumption
Measured: Change from baseline after 5 days of the standardised diet
Asymmetric dimethylarginine, concentration
Marker for meat consumption
Measured: Change from baseline after 5 days of the standardised diet
Homoarginine, concentration
Marker for meat consumption
Measured: Change from baseline after 5 days of the standardised diet
Trimethylamine N-oxide, concentration
Marker for meat consumption
Measured: Change from baseline after 5 days of the standardised diet
Syringol sulfate, concentration
Biomarkers for smoked meat intake
Measured: Change from baseline after 5 days of the standardised diet
Alkylresorcinol, concentration
Markers for consumption of whole grains
Measured: Change from baseline after 5 days of the standardised diet
Wheat germ agglutinin, concentration
Marker for consumption of whole grains
Measured: Change from baseline after 5 days of the standardised diet
Galactitol, concentration
Markers for consumption of dairy products
Measured: Change from baseline after 5 days of the standardised diet
Galactonate, concentration
Markers for consumption of dairy products
Measured: Change from baseline after 5 days of the standardised diet
Galactono-1,5-lactone, concentration
Markers for consumption of dairy products
Measured: Change from baseline after 5 days of the standardised diet
3-phenyllactic acid, concentration
Markers for consumption of dairy products
Measured: Change from baseline after 5 days of the standardised diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start14 Oct 2021
- Primary completion19 Nov 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Standardized diet over five days (n = 4x40) and test meal on day 6 with postprandial profiling (n = 4x12): Four groups characterized by defined intake of: 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)
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
- Investigators
- Christine Dawczynski, PhD, Principal investigator, Friedrich-Schiller-University Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067465
- Sponsor's protocol ID
- H12_21
- Acronym
- Challenge
- Status last verified
- Feb 2023
- First submitted
- 7 Sep 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening to Validate and Identify Nutrition-related Biomarkers for Definded Food Groups (Dairy Products, Whole Grain, Processed Meat, Vegetarian Sausage Alternatives)
- ClinicalTrials.gov ID
- NCT05067465
- Acronym / sponsor ID
- Challenge / H12_21
- Conditions
- Healthy Lifestyle
- Keywords
- dairy products, whole grains, sausage, soy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Standardized diet over five days (n = 4x40) and test meal on day 6 with postprandial profiling (n = 4x12): Four groups characterized by defined intake of: 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)
| Arm | Type | Receives |
|---|---|---|
| Milk and dairy products | Experimental | Dietary Supplement: Selected food groupsStandardized diet over five days (n = 40) - composed of cow milk, cheese, cream cheese, cream, valess milk schnitzel Test meal on day 6 (n = 12) - composed of milk, cheese, cream cheese, cream |
| Whole-grain products (rich in soluble fibers) | Experimental | Dietary Supplement: Selected food groupsStandardized diet over five days (n = 40) - composed of oatmeal, oat bran, oat milk, whole wheat pasta, whole wheat bread, hummus Test meal on day 6 (n = 12) - composed of oatmeal, oat bran, oat milk |
| Sausage and processed meat (pork) | Experimental | Dietary Supplement: Selected food groupsStandardized diet over five days (n = 40) - composed of Lyoner (pig), Viennese (pig), minced meat (pig) Test meal on day 6 (n = 12) - composed of Lyoner (pig), Viennese (pig) |
| Meat-free sausage and meat alternatives (based on egg, pea, soy) | Experimental | Dietary Supplement: Selected food groupsStandardized diet over five days (n = 40) - composed of Mortadella (egg-based), Viennese (egg-based), vegan mince (soy-based) Test meal on day 6 (n = 12) - composed of Mortadella (egg-based), Viennese (egg-based) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selected food groupsFood 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) | Dietary supplement | Meat-free sausage and meat alternatives (based on egg, pea, soy), Milk and dairy products, Sausage and processed meat (pork), Whole-grain products (rich in soluble fibers) |
Primary outcome
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
12 secondary outcomes
1-methylhistidineanserine, concentration
Time frame: Change from baseline after 5 days of the standardised diet
3-methylhistidineanserine, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Asymmetric dimethylarginine, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Homoarginine, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Trimethylamine N-oxide, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Syringol sulfate, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Alkylresorcinol, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Wheat germ agglutinin, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Galactitol, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Galactonate, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Galactono-1,5-lactone, concentration
Time frame: Change from baseline after 5 days of the standardised diet
3-phenyllactic acid, concentration
Time frame: Change from baseline after 5 days of the standardised diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Website of the study centerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Dawczynski, PhD principal investigator
Friedrich-Schiller-University Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected food groups in people with Healthy Lifestyle, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acids, concentration in %fatty acid methyl esters (time frame: Change from baseline after 5 days of the standardised diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.