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Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06645756
Acronym
CAPE
Enrollment
38
Registered
2024-10-17
Start date
2023-12-13
Completion date
2024-11-06
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Weigth, Obesity

Keywords

high-fat diet, high-calorie diet, leukocytes, LPS

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.

Interventions

OTHERTest meal

Test meal consisting of fries, chicken nuggets and eggs

Sponsors

University of Hohenheim
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
LPS30 min after test mealLPS in Serum

Secondary

MeasureTime frameDescription
HbA1cimmediately after the intervention
Serum cytokines and PAMPsimmediately after the intervention
Characterization of PBMCsimmediately after the interventionThe PBMCs are characterized by fluorescence-activated cell sorting (FACS) and RNA isolation.
Metabolome analysesimmediately after the intervention
Trimethylamine / SCFA in serumimmediately after the intervention
Fasting blood glucoseimmediately after the intervention
lipoproteinsimmediately after the intervention
Activability of PBMCs in vitroimmediately after the interventionTo analyze the reactivity of PBMCs, these are isolated, co-cultivated with bacteria and then the number of replicable bacteria is counted.

Other

MeasureTime frame
Fecal microbiome analysisbaseline
IgA in serumimmediately after the intervention
Microbiome RNA in serumbaseline

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026