Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

Not Applicable

Recruiting

• Conditions: Obesity; Normal Weigth

• Registration Number: NCT06645756
• Lead Sponsor: University of Hohenheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Study Start: 2023-12-13
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-17
• Last Update Posted: 2024-10-17
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LPS	240 min after test meal	LPS in Serum

Secondary Outcome Measures

Name	Time	Method
Serum cytokines and PAMPs	immediately after the intervention
HbA1c	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
Activability of PBMCs in vitro	immediately after the intervention	To analyze the reactivity of PBMCs, these are isolated, co-cultivated with bacteria and then the number of replicable bacteria is counted.
Characterization of PBMCs	immediately after the intervention	The PBMCs are characterized by fluorescence-activated cell sorting (FACS) and RNA isolation.

Trial Locations

Locations (1)

Metabolic Unit der Universität Hohenheim; 🇩🇪 Stuttgart, Baden-Württemberg, Germany