Diet, HealthyNCT06147440
Different Dietary Patterns
A study testing Dietary intervention in people with Diet, Healthy and Endotoxemia, run by University of Vienna at 1 site in Austria.
Trial summary
The aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Endotoxemia
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- 20 Oct 2023to Dec 2025
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 kg/m² und 24.9 kg/m²
Who cannot join
- Chronic inflammatory diseases
- Metabolic diseases
- Viral or bacterial infections in the last 3 weeks
- Allergic reactions in the last 3 weeks
- Intake of anti-inflammatory drugs
- Malignant diseases
Show all 12Show fewer
- Pregnancy and lactation
- Smoking
- Alcohol consumption > 10 g/d for women and > 20 g/d for men
- Drug consumption
- Vegetarian or vegan diet
- Food intolerances
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
University of Vienna
Vienna
Ina Bergheim, Prof. Dr., +431427754981, ina.bergheim@univie.ac.at
Annette Brandt, Dr., +43427754984, annette.brandt@univie.ac.at
About this study
Official title: Different Dietary Patterns: Investigations in Healthy Participants
The aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.
- Conditions
- Diet, Healthy, Endotoxemia
- Being tested
- Dietary intervention
- Medical subject headings
- Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
Participants receive diets following different dietary patterns for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Dietary pattern 1 | Experimental | Participants receive a standardized diet following the recommendation of DACH nutrition societies. Receives: Other: Dietary intervention |
| Dietary pattern 2 | Experimental | Participants receive a standardized diet following the recommendation of DACH nutrition societies. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in parameters of intestinal barrier function
Changes in TLR ligand serum levels
Measured: 1 week
Secondary outcomes (3)
Changes in parameters of immune response
Changes in concentration of Interleukin-6 in cell culture supernatant of stimulated immune cells
Measured: 1 week
Changes in blood lipid levels
Changes in triglyceride, cholesterol levels [mg/dl]
Measured: 1 week
Changes in cognitive skills
Assessment of cognitive processes using computer-based psychological tasks (Stroop effect; calculation of differences in response times to incongruent vs. congruent word-color associations)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start20 Oct 2023
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Ina Bergheim, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147440
- Sponsor's protocol ID
- UVienna22
- Status last verified
- Apr 2024
- First submitted
- 31 Oct 2023
- Last updated
- 15 Apr 2025
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Dietary Patterns: Investigations in Healthy Participants
- ClinicalTrials.gov ID
- NCT06147440
- Acronym / sponsor ID
- UVienna22
- Conditions
- Diet, Healthy, Endotoxemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Nov 2023 (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 aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary pattern 1 | Experimental | Other: Dietary interventionParticipants receive a standardized diet following the recommendation of DACH nutrition societies. |
| Dietary pattern 2 | Experimental | Other: Dietary interventionParticipants receive a standardized diet following the recommendation of DACH nutrition societies. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 18.5 kg/m² und 24.9 kg/m²
Key exclusion criteria (12 listed)
- Chronic inflammatory diseases
- Metabolic diseases
- Viral or bacterial infections in the last 3 weeks
- Allergic reactions in the last 3 weeks
- Intake of anti-inflammatory drugs
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 |
|---|---|---|
| Dietary interventionParticipants receive diets following different dietary patterns for 1 week. | Other | Dietary pattern 1, Dietary pattern 2 |
Primary outcome
Changes in parameters of intestinal barrier function
Time frame: 1 week
Changes in TLR ligand serum levels
3 secondary outcomes
Changes in parameters of immune response
Time frame: 1 week
Changes in blood lipid levels
Time frame: 1 week
Changes in cognitive skills
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Diet, Healthy
Not yet recruiting
Nutrition Intervention for Older Adults and Research Training
Impaired Mobility
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
Microbiome
Recruiting
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Major Depressive Disorder (MDD)
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Diet, Healthy and Endotoxemia, run by University of Vienna at 1 site in Austria.
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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Apr 2025. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in parameters of intestinal barrier function (time frame: 1 week). 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 15 Apr 2025.