Clinical trial NCT06645756: Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals
Official title: Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Normal Weigth
Keywords: high-fat diet
high-calorie diet
leukocytes
LPS
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: LPS
timeFrame: 30 min after test meal
measure: LPS
timeFrame: 60 min after test meal
measure: LPS
timeFrame: 120 min after test meal
measure: LPS
timeFrame: 180 min after test meal
measure: LPS
timeFrame: 240 min after test meal
Secondary outcomes:
measure: Activability of PBMCs in vitro
timeFrame: immediately after the intervention
measure: Serum cytokines and PAMPs
timeFrame: immediately after the intervention
measure: Characterization of PBMCs
timeFrame: immediately after the intervention
measure: Metabolome analyses
timeFrame: immediately after the intervention
measure: Trimethylamine / SCFA in serum
timeFrame: immediately after the intervention
measure: Fasting blood glucose
timeFrame: immediately after the intervention
measure: lipoproteins
timeFrame: immediately after the intervention
measure: HbA1c
timeFrame: immediately after the intervention
Other outcomes:
measure: Microbiome RNA in serum
timeFrame: baseline
measure: IgA in serum
timeFrame: immediately after the intervention
measure: Fecal microbiome analysis
timeFrame: baseline
Locations:
city: Stuttgart
country: Germany
facility: Metabolic Unit der Universität Hohenheim
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim
name: Stephan C. Bischoff, Professor
role: PRINCIPAL_INVESTIGATOR
References: