Exploring the Potential of Finger Prick Blood for Assessment of BIOmarkers for LOw Grade Inflammation and CVD Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- LPS_B1
研究概览
简要总结
There are currently no minimally invasive techniques for the measurement of lipopolysaccharide (LPS) and Apo-B48 that can be used in samples collected in field settings. In this project we want to explore whether postprandial assessment of biomarkers LPS and ApoB48 in blood withdrawn with a finger prick test can be used as marker for low grade inflammation and risk factor for CVD.
The primary objectives of this pilot study are to a) determine whether postprandial LPS and ApoB48 levels can be assessed in finger prick blood of both lean subjects and obese subjects; and b) compare postprandial LPS and ApoB48 levels assessed in venous blood and blood collected through a finger prick test.
This study is an observational pilot study in which postprandial LPS and ApoB48 will be assessed before and after ingestion of a high fat load in 5 lean and 5 obese subjects in the age range 18-70 years.
Samples will be collected under fasting conditions and in response to a high fat challenge test (1, 2, 4 and 6 hours post ingestion).
The risks for participation are very small if not negligible. No adverse effects of the high fat challenge were reported previously. Consumption of high amounts of saturated fat may cause some GI discomfort. Blood sampling will be performed via a cannula and the insertion can be a painful and may cause a bruise. Finger prick might also give a short pain sensation and small bruises. The amount of blood that is drawn from participants is relatively small (total 37.5 ml) and is therefore within acceptable limits. There are no direct benefits for the participants. In the BIOLOGIC study we include both lean subjects and obese subjects as we expect differences in postprandial responses related to differences in chylomicron production and LPS levels. Therefore it is important to explore these biomarkers in both target groups. This study can therefore be regarded as group-related, non-therapeutic research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Living in the surroundings of Wageningen (max. 25 km)
- •Stable body weight for past 6 months
- •Suitable veins for insertion of cannula
- •BMI 18.5-22 kg/m2 (lean subjects)
- •BMI ≥ 30 kg/m2 (obese subjects)
排除标准
- •Use of cholesterol-lowering medication (e.g. statins)
- •Use of diabetes medication (e.g. insulin, metformin)
- •Use of antibiotics or anti-inflammatory medication (e.g. NSAIDS such as ibuprofen)
- •Known allergy for any of the food components used in the study (milk, cream, sugars)
- •Blood clotting disorders
- •Current smokers
- •Alcohol consumption of > 21 units per week
- •Participation in another clinical trial at the same time
- •Being an employee of Wageningen Food & Biobased Research
结局指标
主要结局
LPS_B1
时间窗: Baseline
Serum levels LPS venous blood samples under fasting conditions
ApoB48_B1
时间窗: Baseline
Serum levels ApoB48 venous blood samples under fasting conditions
LPS_B2
时间窗: Baseline
Serum levels LPS finger prick blood under fasting conditions
LPS1-1
时间窗: 1 hour post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_B2
时间窗: Baseline
Serum levels ApoB48finger prick blood under fasting conditions
ApoB48_1-1
时间窗: 1 hour post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
LPS2-2
时间窗: 2 hours post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_2-2
时间窗: 2 hours post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS4-1
时间窗: 4 hours post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
LPS1-2
时间窗: 1 hour post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_1-2
时间窗: 1 hour post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS2-1
时间窗: 2 hours post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_2-1
时间窗: 2 hours post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
ApoB48_4-1
时间窗: 4 hours post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
ApoB48_4-2
时间窗: 4 hours post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS6-2
时间窗: 6 hours post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
ApoB48_6-2
时间窗: 6 hours post ingestion
Serum levels ApoB48 finger prick blood after high-fat shake intake
LPS4-2
时间窗: 4 hours post ingestion
Serum levels LPS finger prick blood after high-fat shake intake
LPS6-1
时间窗: 6 hours post ingestion
Serum levels LPS venous blood samples after high-fat shake intake
ApoB48_6-1
时间窗: 6 hours post ingestion
Serum levels ApoB48 venous blood samples after high-fat shake intake
次要结局
- LBP_4(4 hours post ingestion)
- LBP_1(1 hour post ingestion)
- LBP_2(2 hours post ingestion)
- LBP_B(Baseline)
- sCD14_B(Baseline)
- sCD14_1(1 hour post ingestion)
- LBP_6(6 hours post ingestion)
- sCD14_2(2 hours post ingestion)
- sCD14_6(6 hours post ingestion)
- sCD14_4(4 hours post ingestion)
研究者
Diederik Esser
Clinical Trial Coordinator
Wageningen University and Research