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OpenTrials
Completed

NCT Number: NCT06645756

Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metabolic Unit der Universität Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Test meal

Other

Test meal consisting of fries, chicken nuggets and eggs

Primary outcomes

  1. LPS

    Time frame: 30 min after test meal

    LPS in Serum

  2. LPS

    Time frame: 60 min after test meal

    LPS in Serum

  3. LPS

    Time frame: 120 min after test meal

    LPS in Serum

  4. LPS

    Time frame: 180 min after test meal

    LPS in Serum

  5. LPS

    Time frame: 240 min after test meal

    LPS in Serum

Secondary outcomes

  1. Activability of PBMCs in vitro

    Time frame: 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.

  2. Serum cytokines and PAMPs

    Time frame: immediately after the intervention

  3. Characterization of PBMCs

    Time frame: immediately after the intervention

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

  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

Sponsors and collaborators

Lead sponsor

University of Hohenheim

Other

Registry information

Acronym: CAPE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2024
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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