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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01450852
Other study ID # LSU-IRB # 3005
Secondary ID
Status Completed
Phase N/A
First received October 3, 2011
Last updated October 10, 2011
Start date January 2010
Est. completion date May 2010

Study information

Verified date October 2011
Source Louisiana State University Health Sciences Center in New Orleans
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- All Participants Must be Healthy

- The Strength Training Group Members Must Be Approved For Participation by a Licensed MD

Exclusion Criteria:

- Females may not be pregnant

- Unhealthy participants (those with existing conditions)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Strength Training
Each Member of this group completed 12 weeks of progressive, periodized resistance training for 3d/wk.

Locations

Country Name City State
United States Louisiana State University Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Before and After 12 Week of Intervention Period No
Primary 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. Before and After the 12 Week Intervention Period No
Primary 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. Before and After the 12 Week Intervention Period No
Primary 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. Before and After the 12 Week Intervention Period No
Primary 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. Before and After the 12 Week Intervention Period No
Primary 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. Before and After the 12 Week Intervention Period No
Primary 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. Before and After the 12 Week Intevention Period No
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