University of Wisconsin
Madison, Wisconsin, 53705, United States
NCT Number: NCT04857151
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.
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Notify Me21 year–65 year
Female
Interventional
Early Phase 1
Madison, Wisconsin, 53705, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
App based mindfulness program (ABMP)
Time frame: Baseline and 8 weeks
Time frame: 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.
Time frame: Baseline and 8 weeks
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks
Time frame: 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.
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Monocytes will be analyzed by flow cytometry for activation markers and other markers of cell function.
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Wisconsin, Madison
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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