Stress, Inflammation and Immune Response Pilot Study- Aim 3

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Systemic Lupus Erythematosus
• Intervention / Treatment: Behavioral: App based mindfulness program (ABMP)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; Control
Experimental: App based mindfulness program (ABMP); Participants in this group will participate in App based mindfulness program (ABMP)	Behavioral: App based mindfulness program (ABMP); App based mindfulness program (ABMP)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS-GH (Patient-Reported Outcomes Measurement Information System Global Health) score	PROMIS self-report measures are intended to be completed by the respondent without help from anyone else. The PROMIS GH is comprised of 10 global items. Each item represents a different domain of health. Mental health and physical health summary scores are computed and standardized to the general population. Both these component scores and individual global items can be used to assess patients' perceptions of their health. PROMIS global health can be converted to raw scores between 4-20 that can be converted to a t-score of 16.2-67.7. A higher score reflects better functioning.	Baseline and 8 weeks
Change in State Trait Anxiety Inventory (STAI) Score	The State Trail Anxiety Inventory is a 20 item questionnaire about how the participant is feeling. The total possible range of scores is 20-80 lower scores indicate less anxiety.	Baseline and 8 weeks
Change in Five Facet Mindfulness Questionnaire (FFMQ)	FFMQ is a 39-item questionnaire scored on a 5 pt likert scale for a total possible range of scores 39-195 where higher scores indicate increased mindfulness.	Baseline and 8 weeks
Change in the Perceived Stress Scale	The Perceived Stress Scale is a 10-item survey scored on a 5-pt likert scale for a total possible range of scores 0-40 where higher scores indicate increased perceived stress.	Baseline and 8 weeks
Change in PROMIS-Positive Affect Score	The PROMIS-Positive Affect Score is based on a 15-item survey, each item scored on a 5-pt likert scale for a total possible range of scores 15-75 where higher score indicated higher positivity.	Baseline and 8 weeks
Change in PROMIS-Depression Score	The PROMIS-Depression Score is based on a 6-item survey, each item scored on a 5-pt likert scale for a total possible range of scores 6-30 where higher score indicate increased depression.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: David Beebe, PhD, UW Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Meditation; Neutrophil
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Inflammation
• Other Study ID Numbers: 2019-1173- Aim 3; A536300 (Other Identifier: UW Madison); PRJ66UV (Other Grant/Funding Number: UNIVERSITY OF WISCONSIN FOUNDATION); SMPH/PATHOL & LAB MED (Other Identifier: UW Madison); Protocol version 08/29/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No