Stress, Inflammation and Immune Response Pilot Study- Aim 3
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in the expression of stress-induced genes
研究概览
简要总结
The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time.
Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects
Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Lupus diagnosis according to >4 ACR 1987 criteria or >4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist
- •Capacity to provide informed consent and ability to speak and read English
- •BMI under 35
- •Must have access to an iOS or android smartphone to allow daily use of an app
排除标准
- •Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion.
- •History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinological (diabetes), neurologic, rheumatologic, or gastrointestinal disease)
- •Acute illness or evidence of clinically significant active infection
- •Pregnant, breast feeding or less than 6 months post-partum
- •Taking prescribed psychotropic or central nervous system altering medications
- •History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder, epilepsy or seizures
- •Individuals who are currently undergoing a depressive episode. Can include those who are under treatment and not depressed currently.
- •Excluded based upon the screening visit
- •Use of nicotine
- •Significant previous training or significant current practice in meditation
- •Completed Mindfulness Based Stress Reduction (MBSR) in the past
- •Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include))
- •Significant daily practice with other mind-body techniques
- •Daily Yoga or Tai Chi Practice - exclude
- •Other daily practice - judgment
结局指标
主要结局
Change in the expression of stress-induced genes
时间窗: Baseline and 8 weeks
Change in phagocytic index of neutrophils
时间窗: Baseline and 8 weeks
Neutrophil phagocytosis is measured by quantifying the ingestion of fluorescent zymosan or E.coli bioparticles using fluorescence microscopy. A phagocytic index is calculated to report the number of particles phagocytosed per cell.
Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity
时间窗: Baseline and 8 weeks
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and velocity (μm/min) is measured.
Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
时间窗: Baseline and 8 weeks
Change in neutrophil function as assessed by reactive oxygen species (ROS) production
时间窗: Baseline and 8 weeks
Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
时间窗: Baseline and 8 weeks
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and distance (μm) is quantified.
次要结局
- Change in the monocyte activation level(Baseline and 8 weeks)
- Change in inflammatory cytokines level(Baseline and 8 weeks)
- Change in expression of 'immune cells activation markers'(Baseline and 8 weeks)
- Change in the cytokine secretion level from immune cells(Baseline and 8 weeks)
- Change in the methylation pattern of stress-induced genes(Baseline and 8 weeks)
- Change in the gene expression pattern of stress induced genes(Baseline and 8 weeks)