Clinical trial NCT04857151: Stress, Inflammation and Immune Response Pilot Study- Aim 3
Official title: Stress, Inflammation and Immune Response Pilot Study- Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus
Inflammation
Keywords: Neutrophil
Meditation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 3
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
timeFrame: Baseline and 8 weeks
measure: Change in phagocytic index of neutrophils
timeFrame: Baseline and 8 weeks
measure: Change in neutrophil function as assessed by reactive oxygen species (ROS) production
timeFrame: Baseline and 8 weeks
measure: Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity
timeFrame: Baseline and 8 weeks
measure: Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
timeFrame: Baseline and 8 weeks
measure: Change in the expression of stress-induced genes
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in inflammatory cytokines level
timeFrame: Baseline and 8 weeks
measure: Change in expression of 'immune cells activation markers'
timeFrame: Baseline and 8 weeks
measure: Change in the monocyte activation level
timeFrame: Baseline and 8 weeks
measure: Change in the methylation pattern of stress-induced genes
timeFrame: Baseline and 8 weeks
measure: Change in the gene expression pattern of stress induced genes
timeFrame: Baseline and 8 weeks
measure: Change in the cytokine secretion level from immune cells
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Change in PROMIS-GH (Patient-Reported Outcomes Measurement Information System Global Health) score
timeFrame: Baseline and 8 weeks
measure: Change in State Trait Anxiety Inventory (STAI) Score
timeFrame: Baseline and 8 weeks
measure: Change in Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline and 8 weeks
measure: Change in the Perceived Stress Scale
timeFrame: Baseline and 8 weeks
measure: Change in PROMIS-Positive Affect Score
timeFrame: Baseline and 8 weeks
measure: Change in PROMIS-Depression Score
timeFrame: Baseline and 8 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: UW Madison
name: David Beebe, PhD
role: PRINCIPAL_INVESTIGATOR
References: