NCT04857151CompletedEarly phase 1
Stress, Inflammation and Immune Response Pilot Study- Aim 3
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 8 Apr 2021
- Start date
- 2 Feb 2022
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Lupus (SLE)
- NCT number
- NCT04857151
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 3
- From 2 Feb 2022 to the primary completion date, 31 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking prescribed psychotropic or central nervous system altering medications
- Significant previous training or significant current practice in meditation
Other illness
- 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
- History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder, epilepsy or seizures
Other
- Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion.
- Pregnant, breast feeding or less than 6 months post-partum
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 21 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.