Innate Immune ResponseNCT01352871
The Effects of Concentration/Meditation on the Innate Immune Response During Human Endotoxemia
An observational study of Innate Immune Response, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The innate immune response is the first line of defense against invading pathogens. Ideally, the inflammatory response is tightly regulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant or unwanted immune response such as seen in sepsis or auto-immune diseases. Read more about this study
- Who is it for?
- Ages 45 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Innate Immune Response
- What is being tested?
- Concentration / meditation and lipopolysaccharide
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2011to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: One healthy male volunteer that masters the concentration/meditation technique.
Who may be able to join
- 45 - 55 years of age
- male
- Healthy
Who cannot join
- Use of any medication.
- Smoking.
- Bleeding disorder.
- Previous spontaneous vagal collapse.
- History, signs or symptoms of cardiovascular disease.
- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block.
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- Hypertension (defined as RR systolic > 160 or RR diastolic > 90).
- Hypotension (defined as RR systolic < 100 or RR diastolic < 50).
- Renal impairment (defined as plasma creatinin >120 μmol/l).
- Liver enzyme abnormalities or positive hepatitis serology.
- Positive HIV serology or any other obvious disease associated with immune deficiency.
- Febrile illness in the week before the LPS challenge.
- Participation in another drug trial or donation of blood 3 months prior to the planned LPS challenge.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6511HB
About this study
Official title: The Effects of Concentration/Meditation on the Innate Immune Response During
The innate immune response is the first line of defense against invading pathogens. Ideally, the inflammatory response is tightly regulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant or unwanted immune response such as seen in sepsis or auto-immune diseases. It has become increasingly clear that the autonomic nervous system (ANS) and the innate immune response are intimately linked. Activation of the sympathetic division of ANS dampens inflammation via β2-adrenoceptors. On the other hand, in some cases, sympathetic drive can also stimulate the inflammatory response via α2-adrenoceptors. The parasympathetic branch of the ANS modulates the inflammatory response as well, since it was discovered that electrical stimulation of the efferent vagus nerve in rats greatly inhibits the innate immune response. Generally, the ANS is regarded as pure autonomic which can not be influenced by behavior. However, trough special concentration/mediation techniques mastered by certain individuals, it might be possible to modulate ANS activity. In addition, recent unpublished findings indicate that these concentration/meditation techniques can also influence the inflammatory response ex vivo.
In this study the investigators wish to investigate the effect of concentration/meditation on the innate immune response in vivo. In addition the investigators wish to elucidate the mechanism via which this effect is mediated. The investigators aim to use the so called human endotoxemia model. This model permits elucidation of key players in the immune response to a gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting.
Read more
Objectives:
Primary objective: The primary objective of the study is to determine the effect of concentration/meditation on the innate immune response induced by a lipopolysaccharide (LPS) challenge.
Secondary Objective(s):
- To determine the effects of concentration/meditation on ANS activity. Electroencephalography (EEG), heart-rate variability (HRV), muscle sympathetic nerve activity and plasma concentrations of catecholamines will be measured for this purpose.
- To determine if concentration/meditation can attenuate (subclinical) renal damage known to occur during human endotoxemia, markers of proximal and distal tubular damage will be measured at various time points.
- Conditions
- Innate Immune Response
- Being tested
- Concentration / meditation, lipopolysaccharide
- Keywords
- Immunity, Innate, Attention, Concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentration / meditationBehavioural
from 30 minutes before endotoxin administration to 1,5 hrs after endotoxin administration the subject is concentrating / meditating with the goal to influence the innate immune response
lipopolysaccharideDrug
Also called LPS, endotoxin
lipopolysaccharide 2ng/kg intravenously
| Study group | Role | What they receive |
|---|---|---|
| Concentration / meditation | The subject will try to influence the innate immune response by concentration / meditation in advance of and during endotoxemia Receives: Behavioral: Concentration / meditation; Drug: lipopolysaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma TNF-alpha levels
Concentration of circulating TNF-alfa at certain timepoints.
Measured: 0; 1; 1.5; 2; 3; 4; 6; 8; 12; 24 hrs after endotoxin administration
Secondary outcomes (3)
Change in plasma IL-6, IL-10 and IL-1ra levels and leukocyte counts
circulating IL-6, IL-10 and IL-1ra levels at certain timepoints.
Leucocyte count and differentiation will be measured
Measured: 0; 1; 1.5; 2; 3; 4; 6; 8; 12; 24 hrs after endotoxin administration
Change in measures of autonomous nervous system activity
- Electroencephalography (EEG)
- Heart rate variability (HRV)
- Plasma cathecholamines
- Muscle sympathetic nerve activity (MSNA)
Measured: at regulare intervals before and during endotoxemia
Change in markers of subclinical renal tubular damage
determination of markers in urine collected within the above mentioned intervals.
GSTA1-1 will be used as marker for proximal tubular damage GSTP1-1 will be used as marker for distal tubular damage
Measured: before and at 0-3, 3-6, 6-9, 9-12 and 12-24 hrs after endotoxemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Innate Immune ResponseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Peter Pickkers, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352871
- Sponsor's protocol ID
- LPS-concentration
- Status last verified
- Feb 2011
- First submitted
- 26 Nov 2010
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Concentration/Meditation on the Innate Immune Response During
- ClinicalTrials.gov ID
- NCT01352871
- Acronym / sponsor ID
- LPS-concentration
- Conditions
- Innate Immune Response
- Keywords
- Immunity, Innate, Attention, Concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The innate immune response is the first line of defense against invading pathogens. Ideally, the inflammatory response is tightly regulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant or unwanted immune response such as seen in sepsis or auto-immune diseases. It has become increasingly clear that the autonomic nervous system (ANS) and the innate immune response are intimately linked. Activation of the sympathetic division of ANS dampens inflammation via β2-adrenoceptors. On the other hand, in some cases, sympathetic drive can also stimulate the inflammatory response via α2-adrenoceptors. The parasympathetic branch of the ANS modulates the inflammatory response as well, since it was discovered that electrical stimulation of the efferent vagus nerve in rats greatly inhibits the innate immune response. Generally, the ANS is regarded as pure autonomic which can not be influenced by behavior. However, trough special concentration/mediation techniques mastered by certain individuals, it might be possible to modulate ANS activity. In addition, recent unpublished findings indicate that these concentration/meditation techniques can also influence the inflammatory response ex vivo.
In this study the investigators wish to investigate the effect of concentration/meditation on the innate immune response in vivo. In addition the investigators wish to elucidate the mechanism via which this effect is mediated. The investigators aim to use the so called human endotoxemia model. This model permits elucidation of key players in the immune response to a gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting.
Objectives:
Primary objective: The primary objective of the study is to determine the effect of concentration/meditation on the innate immune response induced by a lipopolysaccharide (LPS) challenge.
Secondary Objective(s):
- To determine the effects of concentration/meditation on ANS activity. Electroencephalography (EEG), heart-rate variability (HRV), muscle sympathetic nerve activity and plasma concentrations of catecholamines will be measured for this purpose.
- To determine if concentration/meditation can attenuate (subclinical) renal damage known to occur during human endotoxemia, markers of proximal and distal tubular damage will be measured at various time points.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concentration / meditation | – | Behavioral: Concentration / meditation, Drug: lipopolysaccharideThe subject will try to influence the innate immune response by concentration / meditation in advance of and during endotoxemia |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- One healthy male volunteer that masters the concentration/meditation technique.
Key inclusion criteria (3 listed)
- 45 - 55 years of age
- male
- Healthy
Key exclusion criteria (13 listed)
- Use of any medication.
- Smoking.
- Bleeding disorder.
- Previous spontaneous vagal collapse.
- History, signs or symptoms of cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concentration / meditationfrom 30 minutes before endotoxin administration to 1,5 hrs after endotoxin administration the subject is concentrating / meditating with the goal to influence the innate immune response | Behavioural | Concentration / meditation |
| lipopolysaccharideAlso: LPS, endotoxinlipopolysaccharide 2ng/kg intravenously | Drug | Concentration / meditation |
Primary outcome
Change in Plasma TNF-alpha levels
Time frame: 0; 1; 1.5; 2; 3; 4; 6; 8; 12; 24 hrs after endotoxin administration
Concentration of circulating TNF-alfa at certain timepoints.
3 secondary outcomes
Change in plasma IL-6, IL-10 and IL-1ra levels and leukocyte counts
Time frame: 0; 1; 1.5; 2; 3; 4; 6; 8; 12; 24 hrs after endotoxin administration
Change in measures of autonomous nervous system activity
Time frame: at regulare intervals before and during endotoxemia
Change in markers of subclinical renal tubular damage
Time frame: before and at 0-3, 3-6, 6-9, 9-12 and 12-24 hrs after endotoxemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Pickkers, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Innate Immune Response, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma TNF-alpha levels (time frame: 0; 1; 1.5; 2; 3; 4; 6; 8; 12; 24 hrs after endotoxin administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2011.