Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PRJ66UV | Other Grant/Funding Number | UNIVERSITY OF WISCONSIN FOUNDATION | |
| A536300 | Other Identifier | UW Madison | |
| SMPH/PATHOL & LAB MED | Other Identifier | UW Madison | |
| Protocol version 08/29/2023 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | Control | |
| App based mindfulness program (ABMP) | Experimental | Participants in this group will participate in App based mindfulness program (ABMP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App based mindfulness program (ABMP) | Behavioral | App based mindfulness program (ABMP) |
|
| 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 |
| 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' |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Lupus is about nine times more common in females than in males.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Beebe, PhD | UW Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |