NCT01450852

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 12, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

4 months

First QC Date

October 3, 2011

Last Update Submit

October 10, 2011

Conditions

Keywords

Melanocortin ReceptorMonocyteResistance TrainingInflammationMarkers of Inflammation

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Strength Training

EXPERIMENTAL

The strength training group completed 12 weeks of progressive, periodized resistance training 3d/wk.

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.

Interventions

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

Strength Training

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All Participants Must be Healthy
  • The Strength Training Group Members Must Be Approved For Participation by a Licensed MD

You may not qualify if:

  • Females may not be pregnant
  • Unhealthy participants (those with existing conditions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louisiana State University

Baton Rouge, Louisiana, 70803, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Inflammation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laura K Stewart, PhD

    Louisiana State University Health Sciences Center in New Orleans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 12, 2011

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations