Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals

Last updated: October 14, 2024
Sponsor: University of Hohenheim
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Test meal

Clinical Study ID

NCT06645756
UniHohMet-CAPE-2023
  • Ages > 25
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 tounderstand information and instructions related to the study

Exclusion

Exclusion Criteria:

  • Nicotine consumption

  • High-risk alcohol consumption (more than one standard glass per day for women, morethan 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 (medicalhistory)

  • Participation in another clinical study (current or within the last 30 days prior tostudy entry)

  • A medical condition or regular medication use that, at the investigator'sdiscretion, does not permit study participation or evaluation of study parameters orconsumption of the investigational product (individual decision)

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Test meal
Phase:
Study Start date:
December 13, 2023
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • Metabolic Unit der Universität Hohenheim

    Stuttgart, Baden-Württemberg 70599
    Germany

    Active - Recruiting

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