Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals (CAPE)

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 Overview

• Status: Completed
• Conditions: Obesity; Normal Weigth
• Intervention / Treatment: Other: Test meal

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • Metabolic Unit der Universität Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese group; Test meal	Other: Test meal; Test meal consisting of fries, chicken nuggets and eggs
Experimental: Normal weight group; Test meal	Other: Test meal; Test meal consisting of fries, chicken nuggets and eggs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LPS	LPS in Serum	30 min after test meal
LPS	LPS in Serum	60 min after test meal
LPS	LPS in Serum	120 min after test meal
LPS	LPS in Serum	180 min after test meal
LPS	LPS in Serum	240 min after test meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	immediately after the intervention
Serum cytokines and PAMPs		immediately after the intervention
Characterization of PBMCs	The PBMCs are characterized by fluorescence-activated cell sorting (FACS) and RNA isolation.	immediately after the intervention
Metabolome analyses		immediately after the intervention
Trimethylamine / SCFA in serum		immediately after the intervention
Fasting blood glucose		immediately after the intervention
lipoproteins		immediately after the intervention
HbA1c		immediately after the intervention

Other Outcome Measures

Outcome Measure	Time Frame
Microbiome RNA in serum	baseline
IgA in serum	immediately after the intervention
Fecal microbiome analysis	baseline

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Investigators: Principal Investigator: Stephan C. Bischoff, Professor, University of Hohenheim

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: LPS; leukocytes; high-fat diet; high-calorie diet
• Other Study ID Numbers: UniHohMet-CAPE-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Case-by-case decision after contact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No