Effect of Short Term Time Restricted Eating on Innate Immunity in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- The change in the inflammatory phenotype of circulating immune cells, assessed by measuring the cytokine production capacity (e.g. IL-1b and TNF) of isolated PBMCs after ex vivo stimulation with various TLR ligands, determined by ELISA.
研究概览
简要总结
The goal of this cross over study is to investigate the effect of short term time restricted eating (TRE) on the innate immune system in patients with a history of myocardial infarction.
详细描述
In the recent years, research has shown the prominent role of low grade systemic inflammation in cardiovascular disease (CVD) and the crucial role myeloid cells, mainly monocytes and macrophages, play in atherogenesis. Time restricted eating (TRE), i.e. eating the normal amount of calories within a limited time period per day, has a beneficial effect on multiple factors involved in the development of CVD, such as blood pressure, heart rate, lipid and blood glucose levels, and insulin sensitivity. TRE also reduces markers of systemic inflammation and reduces the number of circulating monocytes.
It is now hypothesized that TRE reduces the pro-inflammatory monocyte phenotype of patients with a history of myocardial infarction. Therefore, the investigators will perform a exploratory prospective randomised open label blinded endpoint cross-over study to investigate the effect of short term TRE on the innate immune system in patients with a history of myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age >18 years)
- •Diagnosed with a myocardial infarction (between 1 and 5 years ago)
- •Body mass index between 20 and 35 kg/m2
- •Able to understand, be motivated and follow the study related procedures
- •Able to understand and give written informed consent
排除标准
- •Myocardial infarction (defined as an increase in cardiac enzymes in combination with symptoms of ischemia or newly developed ischemic ECG changes), coronary artery bypass graft surgery or other major (cardiovascular) surgery, stroke or transient ischemic attack (TIA) in the past 1 year prior to screening.
- •Use of immunomodulatory drugs
- •Use of drugs that need to be taken with food.
- •Diabetes Mellitus type I and type II
- •Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, active malignancy, organ transplant) or auto immune disease
- •Clinically significant infections within 1 months prior to start of or during intervention period or control period (defined as fever >38.5).
- •Vaccination <1 month before start of or during intervention or control period.
- •Eating disorders
结局指标
主要结局
The change in the inflammatory phenotype of circulating immune cells, assessed by measuring the cytokine production capacity (e.g. IL-1b and TNF) of isolated PBMCs after ex vivo stimulation with various TLR ligands, determined by ELISA.
时间窗: Change from baseline cytokine production capacity at 2 weeks after TRE or regular diet.
The investigators will measure the change in the inflammatory phenotype of circulating immune cells after TRE. Therefore, the investigators will assess the inflammatory phenotype at baseline and after a two week TRE period and a control period with a regular diet (cross-over design). This will be assessed by measuring the cytokine production capacity of isolated peripheral blood mononuclear cells (PBMCs) after ex vivo stimulation with various TLR ligands. Relevant cytokines (e.g. IL-1b and TNF, given in pg/ml) are measured in the supernatants of the PMBC stimulation experiments by ELISA.
次要结局
未报告次要终点