Stress, Inflammation and Immune Response Pilot Study- Aim 3

Study Overview
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Brief Summary
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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.

Official Title
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Stress, Inflammation and Immune Response Pilot Study- Aim 3

Conditions
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Systemic Lupus Erythematosus, Inflammation

Intervention / Treatment
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* Behavioral: App based mindfulness program (ABMP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Control | |
| Experimental: App based mindfulness program (ABMP)<br>Participants in this group will participate in App based mindfulness program (ABMP) | Behavioral: App based mindfulness program (ABMP)<br>* App based mindfulness program (ABMP)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation |  | Baseline and 8 weeks | 
| Change in phagocytic index of neutrophils | 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. | Baseline and 8 weeks | 
| Change in neutrophil function as assessed by reactive oxygen species (ROS) production |  | Baseline and 8 weeks | 
| Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity | 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. | Baseline and 8 weeks | 
| Change in neutrophils' migratory ability as assessed by change in distance travelled by neutrophils | 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. | Baseline and 8 weeks | 
| Change in the expression of stress-induced genes |  | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory cytokines level | Peripheral blood mononuclear cells (PBMC) and sub-populations including CD8 T cells and NK cells will be isolated from blood to study inflammatory cytokines level. | Baseline and 8 weeks | 
| Change in expression of 'immune cells activation markers' |  | Baseline and 8 weeks | 
| Change in the monocyte activation level | Monocytes will be analyzed by flow cytometry for activation markers and other markers of cell function. | 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 | 
| Change in the cytokine secretion level from immune cells |  | Baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neutrophil, Meditation