A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in ICAM-1 expression by monocytes
研究概览
简要总结
The aim of the present study is to identify the effects of different dietary fats on the body's immune system and how different types of cells respond. There will be two rounds of recruitment in order to satisfy different aims of the study. In the first round, volunteers will be asked to undergo five separate 1-day assessments where you will be given diets in the form of milkshakes differing in amounts of fats. Volunteers recruited for this round will also be given the opportunity to participate in the second round of recruitment and feeding. A second round of recruitment will then take place to complete recruitment, if required. In the second round, volunteers will be asked to undergo two separate 1-day assessments in the form of milkshakes with differing fats, one of which will contain a tracking label added to the food during preparation. This label is in the form of is a 'stable isotope' and safe to consume (used commonly in some medical tests - see below for further information) and will allow the researchers to later find the food particles within blood cells. During these 1-day assessments blood samples will be collected to identify the impact different diets have on the immune system, specifically monocyte cells thought to play an important role in the development of atherosclerosis, a primary cause of cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy men
- •aged between 18-65 years (inclusive)
- •body mass index of between 18.5-25kg/m2
排除标准
- •Undiagnosed metabolic syndrome (assessed at initial screening)
- •Current smokers
- •Substance abuse
- •Excess alcohol intake
- •Significant medical illness including: diabetes, established cardiovascular disease, cancer, gastrointestinal disease (e.g. inflammatory bowel disease or irritable bowel syndrome), kidney, liver or pancreatic disease or autoimmune or inflammatory disease processes.
- •Taking regular medications
- •Major surgery in last 6 months
研究组 & 干预措施
Healthy, Round 1
For feeding of 5 different fatty acid meals in order to assess the monocyte response ex vivo Mixed high fat diet Low fat diet Saturated fat diet Monounsaturated fat diet Polyunsaturated fat diet
干预措施: Mixed High Fat Diet (Dietary Supplement)
Healthy, Round 1
For feeding of 5 different fatty acid meals in order to assess the monocyte response ex vivo Mixed high fat diet Low fat diet Saturated fat diet Monounsaturated fat diet Polyunsaturated fat diet
干预措施: Saturated fat diet (Dietary Supplement)
Healthy, Round 1
For feeding of 5 different fatty acid meals in order to assess the monocyte response ex vivo Mixed high fat diet Low fat diet Saturated fat diet Monounsaturated fat diet Polyunsaturated fat diet
干预措施: Monounsaturated fat diet (Dietary Supplement)
Healthy, Round 1
For feeding of 5 different fatty acid meals in order to assess the monocyte response ex vivo Mixed high fat diet Low fat diet Saturated fat diet Monounsaturated fat diet Polyunsaturated fat diet
干预措施: Polyunsaturated fat diet (Dietary Supplement)
Healthy, Round 1
For feeding of 5 different fatty acid meals in order to assess the monocyte response ex vivo Mixed high fat diet Low fat diet Saturated fat diet Monounsaturated fat diet Polyunsaturated fat diet
干预措施: Low fat (Dietary Supplement)
Healthy, Round 2
For feeding of 2 different fatty meals, in order to assess the molecular monocyte response and track the fate of fats.
Saturated fat Triolein 13C
干预措施: Saturated fat diet (Dietary Supplement)
Healthy, Round 2
For feeding of 2 different fatty meals, in order to assess the molecular monocyte response and track the fate of fats.
Saturated fat Triolein 13C
干预措施: Triolein 13C (Dietary Supplement)
结局指标
主要结局
Change in ICAM-1 expression by monocytes
时间窗: 3 years
ICAM-1 is a marker of monocyte activation (inflammation). ICAM-1 expression can be measured using flow cytometry techniques to quantify expression and therefore inflammation.
次要结局
- Intracellular lipid volume(3 years)
- Quantity of dietary fatty acid within postprandial monocytes(3 years)