Comparative Analysis of Postprandial Effects in Healthy and Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- LPS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
LPS
时间窗: 240 min after test meal
LPS in Serum
次要结局
- HbA1c(immediately after the intervention)
- Serum cytokines and PAMPs(immediately after the intervention)
- Metabolome analyses(immediately after the intervention)
- Trimethylamine / SCFA in serum(immediately after the intervention)
- Fasting blood glucose(immediately after the intervention)
- lipoproteins(immediately after the intervention)
- Activability of PBMCs in vitro(immediately after the intervention)
- Characterization of PBMCs(immediately after the intervention)
