Stress, Inflammation and Immune Response Pilot Study- Aim 3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2024-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Systemic Lupus Erythematosus Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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control

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

App based mindfulness program (ABMP)

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

Group Type EXPERIMENTAL

App based mindfulness program (ABMP)

Intervention Type BEHAVIORAL

App based mindfulness program (ABMP)

Interventions

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App based mindfulness program (ABMP)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No