Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

NCT ID: NCT06645756

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-13
• Study Completion Date: 2024-11-06

Brief 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.

Conditions

Obesity; Normal Weigth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Obese group

Test meal

Group Type: EXPERIMENTAL

Test meal

Intervention Type: OTHER

Test meal consisting of fries, chicken nuggets and eggs

Normal weight group

Test meal

Group Type: EXPERIMENTAL

Test meal

Intervention Type: OTHER

Test meal consisting of fries, chicken nuggets and eggs

Interventions

Test meal

Test meal consisting of fries, chicken nuggets and eggs

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Hohenheim

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan C. Bischoff, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Locations

Metabolic Unit der Universität Hohenheim

Stuttgart, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

UniHohMet-CAPE-2023

Identifier Type: -

Identifier Source: org_study_id