ClinicalTrials.gg
CompletedNCT06645756CAPEUpdated Aug 6, 2025

Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

An interventional study of Test meal in Obesity and Normal Weigth, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-06.

Sponsored by University of Hohenheim · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
25 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity
  • Normal Weigth

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Keywords

  • high-fat diet
  • high-calorie diet
  • leukocytes
  • LPS
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 38 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Hohenheim is the lead sponsor of 43 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed declaration of consent
  • from 25 years of age
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Taking antacids
  • Manifest diabetes mellitus
  • Acute/unstable cardiovascular diseases
  • Acute inflammatory diseases
  • 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 product (individual decision)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Obese group

    Test meal

    Other: Test meal

  • Experimental
    Normal weight group

    Test meal

    Other: Test meal

Interventions

  • OtherTest meal

    Test meal consisting of fries, chicken nuggets and eggs

06

What researchers measure

Primary outcomes

  1. LPS

    LPS in Serum

    Time frame: 30 min after test meal

  2. LPS

    LPS in Serum

    Time frame: 60 min after test meal

  3. LPS

    LPS in Serum

    Time frame: 120 min after test meal

  4. LPS

    LPS in Serum

    Time frame: 180 min after test meal

  5. LPS

    LPS in Serum

    Time frame: 240 min after test meal

Secondary outcomes

  1. 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.

    Time frame: immediately after the intervention

  2. Serum cytokines and PAMPs

    Time frame: immediately after the intervention

  3. Characterization of PBMCs

    The PBMCs are characterized by fluorescence-activated cell sorting (FACS) and RNA isolation.

    Time frame: immediately after the intervention

  4. Metabolome analyses

    Time frame: immediately after the intervention

  5. Trimethylamine / SCFA in serum

    Time frame: immediately after the intervention

  6. Fasting blood glucose

    Time frame: immediately after the intervention

  7. lipoproteins

    Time frame: immediately after the intervention

  8. HbA1c

    Time frame: immediately after the intervention

Other outcomes

  1. Microbiome RNA in serum

    Time frame: baseline

  2. IgA in serum

    Time frame: immediately after the intervention

  3. Fecal microbiome analysis

    Time frame: baseline

07

Study locations

1 site
  • Metabolic Unit der Universität Hohenheim
    Stuttgart, Baden-Wurttemberg 70599, Germany
08

References and documents

Individual participant data

Plan to share: Undecided — Case-by-case decision after contact

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06645756
Lead sponsor
University of Hohenheim
Responsible party
Sponsor
First posted
Oct 17, 2024
Start date
Dec 13, 2023
Primary completion
Nov 6, 2024
Completion
Nov 6, 2024
Last update
Aug 6, 2025

Study contacts

Stephan C. Bischoff, Professor
principal investigator · University of Hohenheim

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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