NCT06645756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

September 21, 2023

Last Update Submit

July 31, 2025

Conditions

ObesityNormal Weigth

Keywords

high-fat diethigh-calorie dietleukocytesLPS

Outcome Measures

Primary Outcomes (5)

  • LPS

    LPS in Serum

    30 min after test meal

  • LPS

    LPS in Serum

    60 min after test meal

  • LPS

    LPS in Serum

    120 min after test meal

  • LPS

    LPS in Serum

    180 min after test meal

  • LPS

    LPS in Serum

    240 min after test meal

Secondary Outcomes (8)

  • Activability of PBMCs in vitro

    immediately after the intervention

  • Serum cytokines and PAMPs

    immediately after the intervention

  • Characterization of PBMCs

    immediately after the intervention

  • Metabolome analyses

    immediately after the intervention

  • Trimethylamine / SCFA in serum

    immediately after the intervention

  • +3 more secondary outcomes

Other Outcomes (3)

  • Microbiome RNA in serum

    baseline

  • IgA in serum

    immediately after the intervention

  • Fecal microbiome analysis

    baseline

Study Arms (2)

Obese group

EXPERIMENTAL

Test meal

Other: Test meal

Normal weight group

EXPERIMENTAL

Test meal

Other: Test meal

Interventions

Test mealOTHER

Test meal consisting of fries, chicken nuggets and eggs

Normal weight groupObese group

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolic Unit der Universität Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephan C. Bischoff, Professor

    University of Hohenheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 17, 2024

Study Start

December 13, 2023

Primary Completion

November 6, 2024

Study Completion

November 6, 2024

Last Updated

August 6, 2025

Record last verified: 2025-07

Locations

DE(1)