InflammationNCT01450852
Strength Training Induced Alterations in Markers of Immune Function
A study testing Strength Training in people with Inflammation, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
Exercise has been used to help prevent or slow the progression of inflammation-related disease; however, the mechanism by which this activity may lower concentrations of inflammatory markers remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2010
- Phase
- Interventional
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Participants Must be Healthy
- The Strength Training Group Members Must Be Approved For Participation by a Licensed MD
Who cannot join
- Females may not be pregnant
- Unhealthy participants (those with existing conditions)
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University
Baton Rouge, Louisiana, 70803
About this study
Exercise has been used to help prevent or slow the progression of inflammation-related disease; however, the mechanism by which this activity may lower concentrations of inflammatory markers remains unclear. The melanocortin receptors 1,3 and 5 (MC1R, MC3R and MC5R) have been shown to function in an anti-inflammatory manner and have the potential to mediate the positive immune adaptations associated with regular physical activity.
Preliminary data suggest that MC3R gene expression increases in whole blood after chronic exercise training. The primary aim of the current study is to explore whether this change in gene expression translates into alterations in MC1R, MC3R, or MC5R monocyte surface expression. The secondary aim is to examine the relationship between surface expression of these receptors and circulating inflammatory profiles.
The investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. Half of the group will be placed on an exercise program for 15 weeks. The other half will serve as untrained control subjects. In addition to basic anthropometric measures, the investigators will measure concentrations of inflammatory and anti-inflammatory cytokines (ELISA) and cell surface expression of MC1R, MC3R, and MC5R on monocytes (flow cytometry).
Read the detailed description
Abstract:
Chronic exercise reduces inflammation, but the mechanisms involved are unclear. Recent studies have shown that stimulation of melanocortin 1 and 3 receptors (MC1R and MC3R) on immune cells increases anti-inflammatory cytokine production. PURPOSE: To examine the influence of 12 weeks of resistance training (RT) on body composition, monocyte cell-surface expression of MC1R and MC3R and circulating markers of inflammation. METHODS: Healthy, active males and females (age 20-27 yr) were recruited into a RT group (RE; n = 23) and an active control group (AC; n = 19). RE completed 12 weeks of progressive, periodized RT 3d/wk while AC maintained normal activity habits. Measures of body composition (DXA) were taken and blood was collected prior to (PRE) and following the intervention period (POST). Blood samples were analyzed for monocyte cell-surface expression MC1R, MC3R, MC5R and C-reactive protein (CRP) and the plasma cytokines interleukin 6 (IL-6) and interleukin 10 (IL-10) using flow cytometry and ELISAs respectively.
- Conditions
- Inflammation
- Being tested
- Strength Training
- Keywords
- Melanocortin Receptor, Monocyte, Resistance Training, Inflammation, Markers of Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingBehavioural
Each Member of this group completed 12 weeks of progressive, periodized resistance training for 3d/wk.
| Study group | Role | What they receive |
|---|---|---|
| Strength Training | Experimental | The strength training group completed 12 weeks of progressive, periodized resistance training 3d/wk. Receives: Behavioral: Strength Training |
| Active Control Group | No intervention | The active control group was instructed to maintain normal activity and eating habits. They participated in all pre and post intervention measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanocortin 1 Receptor Expression on Monocytes
Blood samples were analyzed for monocyte cell-surface expression of the melanocortin 1 receptor using flow cytometry. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Measured: Before and After 12 Week of Intervention Period
Plasma CRP
Blood samples were analyzed for C-reactive protein using ELISA. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Measured: Before and After the 12 Week Intervention Period
Body Composition (Fat Tissue Amount)
Body composition was assessed using DXA. Pre measures were completed in Jan. 2010 and post measures were completed in May 2010 for all subjects.
Measured: Before and After the 12 Week Intervention Period
Plasma IL-6
Blood samples were analyzed for IL-6 using ELISA. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Measured: Before and After the 12 Week Intervention Period
Plasma IL-10
Blood samples were analyzed for IL-10 using ELISA. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Measured: Before and After the 12 Week Intervention Period
Melanocortin 3 Receptor Cell Surface Expression on Monocytes
Blood samples were analyzed for monocyte cell-surface expression of the melanocortin 3 receptor using flow cytometry. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Measured: Before and After the 12 Week Intervention Period
Melanocortin 5 Receptor Cell Surface Expression on Monocytes
Blood samples were analyzed for monocyte cell-surface expression of the melanocortin 5 receptor using flow cytometry. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Measured: Before and After the 12 Week Intevention Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Stewart, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Laura K Stewart, PhD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450852
- Sponsor's protocol ID
- LSU-IRB # 3005
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Henagan TM, Forney L, Dietrich MA, Harrell BR, Stewart LK. Melanocortin receptor expression is associated with reduced CRP in response to resistance training. J Appl Physiol (1985). 2012 Aug;113(3):393-400. doi: 10.1152/japplphysiol.00107.2012. Epub 2012 Jun 7.
PubMed 22678961
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training Induced Alterations in Markers of Immune Function
- ClinicalTrials.gov ID
- NCT01450852
- Acronym / sponsor ID
- LSU-IRB # 3005
- Conditions
- Inflammation
- Keywords
- Melanocortin Receptor, Monocyte, Resistance Training, Inflammation, Markers of Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Oct 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.
Exercise has been used to help prevent or slow the progression of inflammation-related disease; however, the mechanism by which this activity may lower concentrations of inflammatory markers remains unclear. The melanocortin receptors 1,3 and 5 (MC1R, MC3R and MC5R) have been shown to function in an anti-inflammatory manner and have the potential to mediate the positive immune adaptations associated with regular physical activity.
Preliminary data suggest that MC3R gene expression increases in whole blood after chronic exercise training. The primary aim of the current study is to explore whether this change in gene expression translates into alterations in MC1R, MC3R, or MC5R monocyte surface expression. The secondary aim is to examine the relationship between surface expression of these receptors and circulating inflammatory profiles.
The investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. Half of the group will be placed on an exercise program for 15 weeks. The other half will serve as untrained control subjects. In addition to basic anthropometric measures, the investigators will measure concentrations of inflammatory and anti-inflammatory cytokines (ELISA) and cell surface expression of MC1R, MC3R, and MC5R on monocytes (flow cytometry).
Detailed description
Abstract:
Chronic exercise reduces inflammation, but the mechanisms involved are unclear. Recent studies have shown that stimulation of melanocortin 1 and 3 receptors (MC1R and MC3R) on immune cells increases anti-inflammatory cytokine production. PURPOSE: To examine the influence of 12 weeks of resistance training (RT) on body composition, monocyte cell-surface expression of MC1R and MC3R and circulating markers of inflammation. METHODS: Healthy, active males and females (age 20-27 yr) were recruited into a RT group (RE; n = 23) and an active control group (AC; n = 19). RE completed 12 weeks of progressive, periodized RT 3d/wk while AC maintained normal activity habits. Measures of body composition (DXA) were taken and blood was collected prior to (PRE) and following the intervention period (POST). Blood samples were analyzed for monocyte cell-surface expression MC1R, MC3R, MC5R and C-reactive protein (CRP) and the plasma cytokines interleukin 6 (IL-6) and interleukin 10 (IL-10) using flow cytometry and ELISAs respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Training | Experimental | Behavioral: Strength TrainingThe strength training group completed 12 weeks of progressive, periodized resistance training 3d/wk. |
| Active Control Group | No intervention | –The active control group was instructed to maintain normal activity and eating habits. They participated in all pre and post intervention measures. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All Participants Must be Healthy
- The Strength Training Group Members Must Be Approved For Participation by a Licensed MD
Key exclusion criteria (2 listed)
- Females may not be pregnant
- Unhealthy participants (those with existing conditions)
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 |
|---|---|---|
| Strength TrainingEach Member of this group completed 12 weeks of progressive, periodized resistance training for 3d/wk. | Behavioural | Strength Training |
Primary outcome
Melanocortin 1 Receptor Expression on Monocytes
Time frame: Before and After 12 Week of Intervention Period
Blood samples were analyzed for monocyte cell-surface expression of the melanocortin 1 receptor using flow cytometry. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Plasma CRP
Time frame: Before and After the 12 Week Intervention Period
Blood samples were analyzed for C-reactive protein using ELISA. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Body Composition (Fat Tissue Amount)
Time frame: Before and After the 12 Week Intervention Period
Body composition was assessed using DXA. Pre measures were completed in Jan. 2010 and post measures were completed in May 2010 for all subjects.
Plasma IL-6
Time frame: Before and After the 12 Week Intervention Period
Blood samples were analyzed for IL-6 using ELISA. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Plasma IL-10
Time frame: Before and After the 12 Week Intervention Period
Blood samples were analyzed for IL-10 using ELISA. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Melanocortin 3 Receptor Cell Surface Expression on Monocytes
Time frame: Before and After the 12 Week Intervention Period
Blood samples were analyzed for monocyte cell-surface expression of the melanocortin 3 receptor using flow cytometry. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
Melanocortin 5 Receptor Cell Surface Expression on Monocytes
Time frame: Before and After the 12 Week Intevention Period
Blood samples were analyzed for monocyte cell-surface expression of the melanocortin 5 receptor using flow cytometry. Pre samples were collected in Jan. 2010 and post samples were collected in May 2010 from all subjects.
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 12 Oct 2011.
- Derived from this study: PubMed 22678961Henagan TM, Forney L, Dietrich MA, Harrell BR, Stewart LK. Melanocortin receptor expression is associated with reduced CRP in response to resistance training. J Appl Physiol (1985). 2012 Aug;113(3):393-400. doi: 10.1152/japplphysiol.00107.2012. Epub 2012 Jun 7.
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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.
Laura K Stewart, PhD principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training in people with Inflammation, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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 2 inclusion and 2 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 12 Oct 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 United States. 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?
Melanocortin 1 Receptor Expression on Monocytes (time frame: Before and After 12 Week of Intervention Period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450852, which also lists 1 linked publication.
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 12 Oct 2011.