Stress, Inflammation and Immune Response Pilot Study- Aim 3

NCT04857151 | Completed Early Phase 1

• 5 other identifiers: 2019-1173- Aim 3PRJ66UVA536300SMPH/PATHOL & LAB MEDProtocol version 08/29/2023
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Inflammation

Keywords

Neutrophil; Meditation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Change in 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

  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

Other Outcomes (6)

• Change in PROMIS-GH (Patient-Reported Outcomes Measurement Information System Global Health) score

  Baseline and 8 weeks

• Change in State Trait Anxiety Inventory (STAI) Score

  Baseline and 8 weeks

• Change in Five Facet Mindfulness Questionnaire (FFMQ)

  Baseline and 8 weeks

Study Arms (2)

control

NO INTERVENTION

Control

App based mindfulness program (ABMP)

EXPERIMENTAL

Participants in this group will participate in App based mindfulness program (ABMP)

Behavioral: App based mindfulness program (ABMP)

Interventions

App based mindfulness program (ABMP) BEHAVIORAL

App based mindfulness program (ABMP)

App based mindfulness program (ABMP)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Lupus is about nine times more common in females than in males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Inflammation

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Beebe, PhD

  UW Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 23, 2021
• Study Start: February 2, 2022
• Primary Completion: January 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)