ObesityCAPENCT06645756
Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals
A study testing Test meal in people with Obesity and Normal Weigth, run by University of Hohenheim at 1 site in Germany.
Trial summary
After eating, blood composition changes, including increased triglycerides and glucose, which can trigger postprandial inflammation. Particularly with high-fat foods, pro-inflammatory lipopolysaccharide (LPS) increases. This activates leukocytes to release pro-inflammatory cytokines. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Normal Weigth
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 13 Dec 2023to 6 Nov 2024
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed declaration of consent
- from 25 years of age
- BMI 20 kg/m2 - 25 kg/m2 or BMI 30 kg/m2 - 40 kg/m2
- Good venous conditions for blood collection
- Sufficient understanding of the German language and sufficient mental state to understand information and instructions related to the study
Who cannot join
- Nicotine consumption
- High-risk alcohol consumption (more than one standard glass per day for women, more than two standard glasses per day for men)
- Antibiotic intake
- Taking probiotics, prebiotics and synbiotics, unless taken for more than 90 days
- Taking statins or other lipid-lowering medications (e.g., ezetimibe, fibrates)
- Taking oral antidiabetics
Show all 19Show fewer
- Taking antacids
- Manifest diabetes mellitus
- Acute/unstable cardiovascular diseases
- Acute inflammatory diseases
- autoimmune diseases
- kidney diseases
- food allergy or food intolerance to food components of the test meal (e.g. eggs)
- celiac disease
- Pregnancy and lactation
- Inability to consume the test meal orally
- Placement in a clinic or similar facility due to official or court order (medical history)
- Participation in another clinical study (current or within the last 30 days prior to study entry)
- A medical condition or regular medication use that, at the investigator's discretion, does not permit study participation or evaluation of study parameters or consumption of the investigational product (individual decision)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Metabolic Unit der Universität Hohenheim
Stuttgart, Baden-Wurttemberg, 70599
About this study
After eating, blood composition changes, including increased triglycerides and glucose, which can trigger postprandial inflammation. Particularly with high-fat foods, pro-inflammatory lipopolysaccharide (LPS) increases. This activates leukocytes to release pro-inflammatory cytokines. In industrialized countries where "snacking" is common, many people spend the day in a postprandial state. Obese individuals tend to have chronic inflammation and show increased susceptibility to infections such as SARS-CoV-2. The main objective of the study is to investigate the response of leukocytes and the serum metabolome after food intake in individuals with obesity compared to healthy individuals, focusing on LPS as a key stimulus of innate immunity.
- Conditions
- Obesity, Normal Weigth
- Being tested
- Test meal
- Keywords
- high-fat diet, high-calorie diet, leukocytes, LPS
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mealOther
Test meal consisting of fries, chicken nuggets and eggs
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Experimental | Test meal Receives: Other: Test meal |
| Normal weight group | Experimental | Test meal Receives: Other: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPS
LPS in Serum
Measured: 30 min after test meal
LPS
LPS in Serum
Measured: 60 min after test meal
LPS
LPS in Serum
Measured: 120 min after test meal
LPS
LPS in Serum
Measured: 180 min after test meal
LPS
LPS in Serum
Measured: 240 min after test meal
Secondary outcomes (8)
Activability of PBMCs in vitro
To analyze the reactivity of PBMCs, these are isolated, co-cultivated with bacteria and then the number of replicable bacteria is counted.
Measured: immediately after the intervention
Serum cytokines and PAMPs
Measured: immediately after the intervention
Characterization of PBMCs
The PBMCs are characterized by fluorescence-activated cell sorting (FACS) and RNA isolation.
Measured: immediately after the intervention
Metabolome analyses
Measured: immediately after the intervention
Trimethylamine / SCFA in serum
Measured: immediately after the intervention
Fasting blood glucose
Measured: immediately after the intervention
lipoproteins
Measured: immediately after the intervention
HbA1c
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start13 Dec 2023
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan C. Bischoff, Professor, Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645756
- Sponsor's protocol ID
- UniHohMet-CAPE-2023
- Acronym
- CAPE
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Case-by-case decision after contact
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals
- ClinicalTrials.gov ID
- NCT06645756
- Acronym / sponsor ID
- CAPE / UniHohMet-CAPE-2023
- Conditions
- Obesity, Normal Weigth
- Keywords
- high-fat diet, high-calorie diet, leukocytes, LPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 17 Oct 2024 (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.
After eating, blood composition changes, including increased triglycerides and glucose, which can trigger postprandial inflammation. Particularly with high-fat foods, pro-inflammatory lipopolysaccharide (LPS) increases. This activates leukocytes to release pro-inflammatory cytokines. In industrialized countries where "snacking" is common, many people spend the day in a postprandial state. Obese individuals tend to have chronic inflammation and show increased susceptibility to infections such as SARS-CoV-2. The main objective of the study is to investigate the response of leukocytes and the serum metabolome after food intake in individuals with obesity compared to healthy individuals, focusing on LPS as a key stimulus of innate immunity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | Experimental | Other: Test mealTest meal |
| Normal weight group | Experimental | Other: Test mealTest meal |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed declaration of consent
- from 25 years of age
- BMI 20 kg/m2 - 25 kg/m2 or BMI 30 kg/m2 - 40 kg/m2
- Good venous conditions for blood collection
- Sufficient understanding of the German language and sufficient mental state to understand information and instructions related to the study
Key exclusion criteria (19 listed)
- Nicotine consumption
- High-risk alcohol consumption (more than one standard glass per day for women, more than two standard glasses per day for men)
- Antibiotic intake
- Taking probiotics, prebiotics and synbiotics, unless taken for more than 90 days
- Taking statins or other lipid-lowering medications (e.g., ezetimibe, fibrates)
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 |
|---|---|---|
| Test mealTest meal consisting of fries, chicken nuggets and eggs | Other | Normal weight group, Obese group |
Primary outcome
LPS
Time frame: 30 min after test meal
LPS in Serum
LPS
Time frame: 60 min after test meal
LPS in Serum
LPS
Time frame: 120 min after test meal
LPS in Serum
LPS
Time frame: 180 min after test meal
LPS in Serum
LPS
Time frame: 240 min after test meal
LPS in Serum
8 secondary outcomes
Activability of PBMCs in vitro
Time frame: immediately after the intervention
Serum cytokines and PAMPs
Time frame: immediately after the intervention
Characterization of PBMCs
Time frame: immediately after the intervention
Metabolome analyses
Time frame: immediately after the intervention
Trimethylamine / SCFA in serum
Time frame: immediately after the intervention
Fasting blood glucose
Time frame: immediately after the intervention
lipoproteins
Time frame: immediately after the intervention
HbA1c
Time frame: immediately after the intervention
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 Aug 2025.
- Individual participant dataSharing planned: Undecided. Case-by-case decision after contact
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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.
Stephan C. Bischoff, Professor principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal in people with Obesity and Normal Weigth, run by University of Hohenheim 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 5 inclusion and 19 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 Aug 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 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?
LPS (time frame: 30 min after test meal). The study lists 5 primary outcomes in all. 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 Aug 2025.