Stress, Inflammation and Immune Response Pilot Study- Aim 3

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Recruiting
CT.gov ID
NCT04857151
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
24.9
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: App based mindfulness program (ABMP)
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Stress, Inflammation and Immune Response Pilot Study- Aim 3
Actual Study Start Date :
Feb 2, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

ArmIntervention/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)

Outcome Measures

Primary Outcome Measures

  1. Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation [Baseline and 8 weeks]

  2. Change in phagocytic index of neutrophils [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.

  3. Change in neutrophil function as assessed by reactive oxygen species (ROS) production [Baseline and 8 weeks]

  4. Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity [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.

  5. Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils [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.

  6. Change in the expression of stress-induced genes [Baseline and 8 weeks]

Secondary Outcome Measures

  1. Change in inflammatory cytokines level [Baseline and 8 weeks]

    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.

  2. Change in expression of 'immune cells activation markers' [Baseline and 8 weeks]

  3. Change in the monocyte activation level [Baseline and 8 weeks]

    Monocytes will be analyzed by flow cytometry for activation markers and other markers of cell function.

  4. Change in the methylation pattern of stress-induced genes [Baseline and 8 weeks]

  5. Change in the gene expression pattern of stress induced genes [Baseline and 8 weeks]

  6. Change in the cytokine secretion level from immune cells [Baseline and 8 weeks]

Other Outcome Measures

  1. Change in PROMIS-GH (Patient-Reported Outcomes Measurement Information System Global Health) score [Baseline and 8 weeks]

    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.

  2. Change in State Trait Anxiety Inventory (STAI) Score [Baseline and 8 weeks]

    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.

  3. Change in Five Facet Mindfulness Questionnaire (FFMQ) [Baseline and 8 weeks]

    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.

  4. Change in the Perceived Stress Scale [Baseline and 8 weeks]

    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.

  5. Change in PROMIS-Positive Affect Score [Baseline and 8 weeks]

    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.

  6. Change in PROMIS-Depression Score [Baseline and 8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of WisconsinMadisonWisconsinUnited States53705

Sponsors and Collaborators

  • University of Wisconsin, Madison

Investigators

  • Principal Investigator: David Beebe, PhD, UW Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT04857151
Other Study ID Numbers:
  • 2019-1173- Aim 3
  • PRJ66UV
  • A536300
  • SMPH/PATHOL & LAB MED
  • Protocol version: 3/22/2021
First Posted:
Apr 23, 2021
Last Update Posted:
Feb 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Wisconsin, Madison
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2022