Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617351
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
This Repeated Measures Parallel-group Investigation Will Examine the Influence of Short-term Melatonin Supplementation 5mg 3 x Day for 72 Hours on Cellular Responses Functional Performance and Recovery Following an Acute Bout of Dynamic Resistance Exercise in Resistance Trained Men and Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Melatonin Supplementation on Immune Cell Responses and Functional Recovery Following Acute Resistance Exercise
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral Melatonin is a commercially available product available alone and as a constituent in a number of supplements Previous research suggests that short-term supplementation with oral melatonin may amplify the recovery response to damaging resistance exercise via modulation of subsequent immune and inflammatory responses However the effects of oral melatonin on neutrophil and monocyte invasionmigration a critical step in the resolution of skeletal muscle tissue homeostasis has not been examined An oral melatonin supplement 5mg will be provided three times daily beginning 24-hours before and ending 48-hours after an acute bout of damaging resistance exercise total 15mgday for 3 days
Goals
1 To investigate the effect of melatonin on systemic and cellular responses following an acute bout of damaging resistance exercise
2 To investigate the effect of melatonin on measures of functional performance before and during recovery from an acute bout of damaging resistance exercise
Goals
1 To investigate the effect of melatonin on systemic and cellular responses following an acute bout of damaging resistance exercise
2 To investigate the effect of melatonin on measures of functional performance before and during recovery from an acute bout of damaging resistance exercise
Detailed Description:
Resistance exercise of sufficient intensity can result in localized damage to skeletal muscle tissue The resolution of tissue homeostasis following damaging exercise is mediated largely by neutrophils and monocytes of the innate immune system 1 Neutrophils and monocytes originate in the systemic circulation and infiltrate the damaged tissue following activation and migration in response to damage associated molecular cues These cells are reported to execute a number of processes fundamental to recovery including the phagocytosis of opsonized cellular debris 2 and secretion of mitogenic factors that stimulate both the proliferation and differentiation of myogenic precursor cells 3 Disruption of this cellular response has been shown to lead to impaired muscle regeneration and a subsequent deficit in muscle fiber size 4 Accordingly a successful innate immune response is paramount for optimal tissue regeneration
Several supplements have been introduced to the market with purported claims of enhanced recovery from exercise One potential mechanism for enhanced recovery is through augmentation of the immune response which may allow for a more pronounced stimulus to enhance repair 1 Previous research suggests that short-term supplementation with melatonin an endogenously produced indoleamine may amplify the recovery response Melatonin receptors are expressed on most immune cell types including monocytes neutrophils and Th1 lymphocytes 5 Melatonin has previously been shown to activate monocytes 6 and treatment with melatonin has been shown to upregulate the recruitment of human monocytes through interaction with the melatonin receptor MLTr in vitro Melatonin has also been shown to alter cytokine production and increase the production of cells of both the innate and adaptive immune system 7 Binding of melatonin to MLTrs expressed on immune cells may modulate recruitment of these cells to damaged tissue which may in turn regulate the ensuing recovery response Theoretically this could reduce recovery time following damaging exercise improving quality of training and potentially allow for enhanced performance over time 8910 Nevertheless the effect of short-term melatonin supplementation on innate immune cell and inflammatory responses during recovery from resistance exercise has not been examined
Goals
1 To assess systemic and cellular responses to an acute bout of resistance exercise between participants ingesting melatonin versus placebo including creatine kinase CK complete blood counts CBC serum interleukin-8 IL-8 serum monocyte chemoattractant protein-1 MCP-1 serum melatonin serum C-reactive protein CRP cell receptor expression monocytes activated CD11b CCR2 MLTr1A neutrophils activated CD11b CXCR2 MLTr1A and neutrophilmonocyte invasionmigration dynamics cell index CI
2 To assess functional measures of recovery following an acute bout of resistance exercise between participants ingesting melatonin versus placebo including subjective sleep qualityduration fatigue soreness and stress Hooper Questionnaire perceived Recovery Perceived Recovery Status Scale PRSS active range of motion AROM pain pressure threshold PPT countermovement jump CMJ squat maximal voluntary isometric contraction MVIC and objective sleep and physical activity Accelerometry
Method
Randomized double-blind placebo controlled parallel-groups trial comparing the effect of supplementation with Melatonin versus Placebo on systemic and cellular responses and functional recovery from damaging resistance exercise
Melatonin or placebo supplementation randomly assigned will occur over a period of 3 days beginning 24-hours prior to completion of an acute bout of damaging resistance exercise through a 48-hours post-exercise recovery period
Objective sleep and physical activity accelerometry will be assessed 24-hours before -24H 24-hours Post 24H and 48-Hours 48H post-exercise Diet carbohydrates fats proteins total calories and micronutrients will be assessed at Pre 0 24H and 48H post-exercise CBC CK IL-8 MCP-1 CRP Hooper PRSS AROM PPT CMJ MVIC and melatonin will be assessed at Pre 0 immediately- post IP 4-hours post 4H 24H and 48H post-exercise Neutrophil cell index will be assessed at Pre 0 4H and 24H post-exercise Monocyte cell index CI will be assessed at Pre 0 24H and 48H post-exercise Neutrophil cell receptor expression will be assessed at Pre 0 4H and 24H Monocyte receptor expression will be assessed at Pre 0 24H and 48H
Several supplements have been introduced to the market with purported claims of enhanced recovery from exercise One potential mechanism for enhanced recovery is through augmentation of the immune response which may allow for a more pronounced stimulus to enhance repair 1 Previous research suggests that short-term supplementation with melatonin an endogenously produced indoleamine may amplify the recovery response Melatonin receptors are expressed on most immune cell types including monocytes neutrophils and Th1 lymphocytes 5 Melatonin has previously been shown to activate monocytes 6 and treatment with melatonin has been shown to upregulate the recruitment of human monocytes through interaction with the melatonin receptor MLTr in vitro Melatonin has also been shown to alter cytokine production and increase the production of cells of both the innate and adaptive immune system 7 Binding of melatonin to MLTrs expressed on immune cells may modulate recruitment of these cells to damaged tissue which may in turn regulate the ensuing recovery response Theoretically this could reduce recovery time following damaging exercise improving quality of training and potentially allow for enhanced performance over time 8910 Nevertheless the effect of short-term melatonin supplementation on innate immune cell and inflammatory responses during recovery from resistance exercise has not been examined
Goals
1 To assess systemic and cellular responses to an acute bout of resistance exercise between participants ingesting melatonin versus placebo including creatine kinase CK complete blood counts CBC serum interleukin-8 IL-8 serum monocyte chemoattractant protein-1 MCP-1 serum melatonin serum C-reactive protein CRP cell receptor expression monocytes activated CD11b CCR2 MLTr1A neutrophils activated CD11b CXCR2 MLTr1A and neutrophilmonocyte invasionmigration dynamics cell index CI
2 To assess functional measures of recovery following an acute bout of resistance exercise between participants ingesting melatonin versus placebo including subjective sleep qualityduration fatigue soreness and stress Hooper Questionnaire perceived Recovery Perceived Recovery Status Scale PRSS active range of motion AROM pain pressure threshold PPT countermovement jump CMJ squat maximal voluntary isometric contraction MVIC and objective sleep and physical activity Accelerometry
Method
Randomized double-blind placebo controlled parallel-groups trial comparing the effect of supplementation with Melatonin versus Placebo on systemic and cellular responses and functional recovery from damaging resistance exercise
Melatonin or placebo supplementation randomly assigned will occur over a period of 3 days beginning 24-hours prior to completion of an acute bout of damaging resistance exercise through a 48-hours post-exercise recovery period
Objective sleep and physical activity accelerometry will be assessed 24-hours before -24H 24-hours Post 24H and 48-Hours 48H post-exercise Diet carbohydrates fats proteins total calories and micronutrients will be assessed at Pre 0 24H and 48H post-exercise CBC CK IL-8 MCP-1 CRP Hooper PRSS AROM PPT CMJ MVIC and melatonin will be assessed at Pre 0 immediately- post IP 4-hours post 4H 24H and 48H post-exercise Neutrophil cell index will be assessed at Pre 0 4H and 24H post-exercise Monocyte cell index CI will be assessed at Pre 0 24H and 48H post-exercise Neutrophil cell receptor expression will be assessed at Pre 0 4H and 24H Monocyte receptor expression will be assessed at Pre 0 24H and 48H
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None