AzTrials
AzTrials

Cell MigrationNCT06617351

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

A study testing Melatonin in people with Cell Migration and Cell Invasion, run by University of Central Florida at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cell Migration, Cell Invasion, Exercise Recovery
What is being tested?
Melatonin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 31 Jul 2025
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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female between the ages of 18-40 years old.
  • Healthy and ready for physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q+) and Medical History Questionnaire (MHQ).
  • Active resistance training for a minimum of 6 months as defined by 3 resistance training sessions (muscle strengthening activities such as free weights, weight machines, or calisthenics, etc.) per week with at least one lower body session as determined by the training history questionnaire.
  • Premenopausal, with an identifiable onset of menses (early follicular phase) as determined by the menstrual status questionnaire (female participants only)..
  • Not currently pregnant and no intention to become pregnant for the duration of participation (female participants only).
  • Currently free from and willing to abstain from dietary supplements that are viewed by study investigators to confound the outcomes of the study (e.g., creatine, beta-alanine) for the duration of the study. Participants currently using supplements will be permitted to enroll in the study following a 4-week washout period of these supplements.
Show all 11Show fewer
  • Willing to adhere to all pre-testing visit instructions including abstaining from exercise for the duration of the study and abstaining from alcohol for 24 hours prior to visit 2 as well as for 24 hours before visit 3 until completion of the study.
  • Currently be consuming ≤ 300mg caffeine per day on average and willing to keep caffeine intake consistent throughout the duration of the study. Participants must also be willing to abstain from caffeine intake for 12 hours prior to visits 3, 4 and 5 and not consume caffeine the morning of these visits.
  • Free from previous or current lower body injuries that are viewed by the investigators to potentially limit ability of the participant to perform the exercise intervention or functional assessments.
  • Not regularly taking any type of prescription or over-the-counter medication which might affect the assessments, or having any chronic illnesses, which require medical care.
  • Considered by the study investigators to have a high likelihood of successful venipuncture following an initial examination of the participants antecubital fossa by a certified phlebotomist and verbal discussion of the participants blood draw history (including history of unsuccessful venipunctures, known issues with the locating/palpating of veins in the antecubital fossa by a phlebotomist, and whether these difficulties are more apparent on one arm compared to the other).

Who cannot join

  • Individual does not agree to participate in this study.
  • Individual does not meet inclusion criteria to participate in the study protocols as determined via the PAR-Q+, medical history questionnaire, training history questionnaire, and/or the caffeine consumption questionnaire.
  • Currently taking melatonin
  • Regularly taking any type of prescription or over-the-counter medication which might affect the assessments, or having any chronic illnesses, which require medical care.
  • Not currently meeting requirements for resistance trained status.
  • Current known pregnancy or intent to become pregnant during the study period.
Show all 10Show fewer
  • Not regularly having periods or amenorrheic, as determined by Menstrual Status Questionnaire (MSQ).
  • Currently taking any performance-enhancing drug (determined from health and activity questionnaire).
  • Currently taking a nutritional supplement viewed by the research team to confound the outcomes of the study and not willing to abstain from taking the supplement during the course of the study or not willing to undergo a 4-week wash-out period prior to participating if required.
  • Evaluated as having a low likelihood of successful venipuncture by a certified phlebotomist.

Trial locations and contacts

1 site in 1 country.

Adam J Wells, PhD contact

407-823-3906

adam.wells@ucf.edu

Kadie Drahos, BS contact

716-946-1619

kadie.drahos@ucf.edu

United States1 site

  • Kinesiology Research Labs

    Orlando, Florida, 32816

Other trials in United States

About this study

Official title: The Effect of Melatonin Supplementation on Immune Cell Responses and Functional Recovery Following Acute Resistance Exercise

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 invasion/migration, 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 15mg/day 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.
Read the 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 MLTr's 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 (8,9,10). 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 neutrophil/monocyte invasion/migration 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 quality/duration, 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.

Being tested
Melatonin, Placebo
Keywords
melatonin, exercise recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MelatoninDietary supplement

    Gummy - 7.5 kilocalories (kCal), 2 g Carbohydrate, 1.5 g total sugars, 7.5 mg sodium, 5 mg melatonin.

  • PlaceboDietary supplement

    Gummy - 12.5 kilocalories (kCal), 3g Carbohydrate, 1.875 g total sugars, 1.25 mg sodium.

Study groups in NCT06617351
Study groupRoleWhat they receive
MelatoninExperimentalParticipants will receive Melatonin (5mg, 3 times daily with breakfast, lunch and dinner) beginning 24 hours before and ending 48 hours following an acute bout of dynamic high-intensity resistance exercise. On the day of the exercise bout, participants will ingest a single dose of Melatonin prior to arriving at the lab and following all testing procedures. Melatonin formula: 7.5 kCal, 2 g Carbohydrate, 1.5 g total sugars, 7.5 mg sodium, 5 mg melatonin.
Receives: Dietary Supplement: Melatonin
PlaceboPlacebo comparatorParticipants will receive Placebo (3 times daily with breakfast, lunch and dinner) beginning 24 hours before and ending 48 hours following an acute bout of dynamic high-intensity resistance exercise. On the day of the exercise bout, participants will ingest a single dose of the placebo prior to arriving at the lab and following all testing procedures. Placebo formula: 12.5 kCal, 3g Carbohydrate, 1.875 g total sugars, 1.25 mg sodium.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Sleep Duration

    Participants provide information about sleep duration the previous night using the Hooper Questionnaire administered via pen and paper. Response is rated on a seven-point Likert scale with the following responses:

    • 10+
    • 9-10
    • 8-9
    • 8
    • 7-8
    • 5-7
    • 5 or less

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  2. Subjective Sleep Quality

    Participants provide information about their sleep quality the previous night using the Hooper Questionnaire administered via pen and paper. Response is rated on a seven-point Likert scale with the following responses:

    • Outstanding
    • Very good
    • Good
    • Better than normal
    • Worse than normal
    • Disrupted
    • Horrible - No Sleep

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  3. Subjective Fatigue

    Participants provide information about their current level of fatigue using the Hooper Questionnaire administered via pen and paper. Response is rated on a seven-point Likert scale with the following responses:

    • No Fatigue
    • Minimal Fatigue
    • Better than normal
    • Normal
    • Worse than normal
    • Very Fatigued
    • Exhausted - Major fatigue

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  4. Subjective Muscle Soreness

    Participants provide information about their current level of muscle soreness using the Hooper Questionnaire administered via pen and paper. Response is rated on a seven-point Likert scale with the following responses:

    • No Soreness
    • Very little soreness
    • Better than normal
    • Normal
    • Worse than normal
    • Very sore/tight
    • Extremely sore/tight

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  5. Subjective Mental Stress

    Participants provide information about their current level of mental stress using the Hooper Questionnaire administered via pen and paper. Response is rated on a seven-point Likert scale with the following responses:

    • Feeling great - Very relaxed
    • Feeling Good - Relaxed
    • Better than normal
    • Normal
    • Worse than normal
    • Stressed
    • Very Stressed

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  6. Perceived Recovery Status

    Participants provide information about their perceived recovery status using the Perceived Recovery Status Scale (PRSS). Response is rated on a scale ranging from 0 (very poorly recovered/extremely tired) to 10 (very well recovered/highly energetic). Each response also corresponds to a broader performance categorization with values indicating expectations of either declined performance, similar performance, or improved performance relative to subsequent time points.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  7. Active Range of Motion (AROM)

    Assessed in both lower limbs via handheld goniometer while participant is supine. Average of two measures on each limb is used to determine AROM.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  8. Pain Pressure Threshold (PPT)

    Assessed in dominant lower limb via manual algometer while participant is supine. PPT is defined as the point at which the pressure applied via the algometer becomes uncomfortable, as verbally indicated by the participant. PPT is measured in triplicate with 10 seconds of rest between measurements. Average of the three measures is used to determine PPT.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  9. Peak Jump Height

    Determined via counter movement jump performed using portable force plate system. Peak Jump height is the highest jump height across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  10. Mean Jump Height

    Determined via counter movement jump performed using portable force plate system. Mean Jump height is the average jump height across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  11. Peak Jump Force

    Determined via counter movement jump performed using portable force plate system. Peak force is the highest force achieved across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  12. Mean Jump Force

    Determined via counter movement jump performed using portable force plate system. Mean Jump force is the average jump force across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  13. Peak Braking Force

    Determined via counter movement jump performed using portable force plate system. Peak braking force is the highest braking force achieved across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  14. Mean Braking Force

    Determined via counter movement jump performed using portable force plate system. Mean braking force is the average braking force across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  15. Peak Braking Rate of Force Development (RFD)

    Determined via counter movement jump performed using portable force plate system. Peak braking rate of force development force is the peak braking RFD force achieved across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  16. Mean Braking Rate of Force Development (RFD)

    Determined via counter movement jump performed using portable force plate system. Mean braking rate of force development is the average braking RFD force across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  17. Mean Reactive Strength Index (RSI)

    Determined via counter movement jump performed using portable force plate system. Defined as the time taken to complete the flight phase divided by the total time taken from the initiation of movement to the instant of take-off. Mean RSI is the average RSI across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  18. Peak Reactive Strength Index (RSI)

    Determined via counter movement jump performed using portable force plate system. Defined as the time taken to complete the flight phase divided by the total time taken from the initiation of movement to the instant of take-off. Peak RSI is the peak RSI achieved across 3 jumps separated by 30 seconds.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  19. Squat Maximal Voluntary Isometric Contraction (MVIC) Force

    Determined via isometric squat contraction using portable force plate system and isometric squat rack with fixed bar. Participants will complete three 5-second isometric contractions with one minute of rest between contractions. The highest force achieved during the three contractions will be recorded as Squat MVIC force.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  20. Squat Maximal Voluntary Isometric Contraction (MVIC) Rate of Force Development (RFD)

    Determined via isometric squat contraction using portable force plate system and isometric squat rack with fixed bar. Participants will complete three 5-second isometric contractions with one minute of rest between contractions. Rate of force development (RFD), dictated by the onset of muscular contraction, will be recorded at 0-300ms for the contraction with the highest peak force.

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  21. Objective Sleep Quality

    Assessed using an ActiGraph GT9X Link accelerometer. Participants will wear the accelerometer and beginning 24 hours before the resistance exercise protocol through 48-hours post-exercise. Number of minutes that participants are asleep, and the number of times their sleep is disrupted will be assessed.

    Measured: -24 hours before (-24H), 24-hours Post (24H), 48-hours Post (48H)

  22. Physical Activity

    Assessed using an ActiGraph GT9X Link accelerometer. Participants will wear the accelerometer and beginning 24 hours before the resistance exercise protocol through 48-hours post-exercise. Minutes per day that participants engage in low, moderate, and high intensity physical activity will be assessed.

    Measured: -24 hours before (-24H), 24-hours Post (24H), 48-hours Post (48H)

  23. Hematocrit

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  24. Hemoglobin

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  25. Mean corpuscular volume (MCV)

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  26. Mean corpuscular hemoglobin (MCH)

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  27. Mean corpuscular hemoglobin concentration (MCHC)

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  28. Total white blood cell count (WBC)

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  29. Total red blood cell count (RBC)

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  30. Lymphocyte Count

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  31. Monocyte Count

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  32. Granulocyte Count

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  33. Platelet Count

    Assessed via Automated Hematology Analyzer

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  34. Serum Creatine Kinase (CK) concentration

    Marker of muscle damage. Assessed via assay and microplate reader

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  35. Serum Melatonin concentration

    Assessed via assay and microplate reader

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  36. Serum C-reactive protein (CRP) concentration

    Assessed via assay and microplate reader

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  37. Serum Interleukin-8 (IL-8) concentration

    Assessed via assay and microplate reader

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  38. Serum Monocyte Chemoattractant Protein-1 (MCP-1) concentration

    Assessed via assay and microplate reader

    Measured: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)

  39. Monocyte Cell Index (CI)

    Assessed via Real Time Cell Analysis (RTCA) assay

    Measured: Pre (0), 24-hours post (24H), 48-hours post (48H)

  40. Neutrophil Cell Index (CI)

    Assessed via Real Time Cell Analysis (RTCA) assay

    Measured: Pre (0), 4-Hours Post (4H), 24-hours post (24H)

  41. Monocyte C-C chemokine receptor 2 (CCR2) expression

    Assessed via flow cytometry

    Measured: Pre (0), 24-hours post (24H), 48-hours post (48H)

  42. Monocyte Macrophage-1 antigen (Integrin CD11b) expression

    Assessed via flow cytometry

    Measured: Pre (0), 24-hours post (24H), 48-hours post (48H)

  43. Monocyte Melatonin Receptor 1A (MLTr1A) expression

    Assessed via flow cytometry

    Measured: Pre (0), 24-hours post (24H), 48-hours post (48H)

  44. Neutrophil Receptor 1A (MLTr1A) expression

    Assessed via flow cytometry

    Measured: Pre (0), 4-Hours Post (4H), 24-hours post (24H)

  45. Neutrophil Macrophage-1 antigen (Integrin CD11b) expression

    Assessed via flow cytometry

    Measured: Pre (0), 4-Hours Post (4H), 24-hours post (24H)

  46. Neutrophil Interleukin-8 receptor (CXCR2) expression

    Assessed via flow cytometry

    Measured: Pre (0), 4-Hours Post (4H), 24-hours post (24H)

  47. Diet - Daily Protein

    Assessed via Automated Self-Administered 24hr Dietary Recall (ASA24).

    Measured: Pre (0), 24-hours Post (24H), 48-hours Post (48H)

  48. Diet - Daily Carbohydrate

    Assessed via Automated Self-Administered 24hr Dietary Recall (ASA24).

    Measured: Pre (0), 24-hours Post (24H), 48-hours Post (48H)

  49. Diet - Daily Fat

    Assessed via Automated Self-Administered 24hr Dietary Recall (ASA24).

    Measured: Pre (0), 24-hours Post (24H), 48-hours Post (48H)

  50. Diet - Daily Total Calories

    Assessed via Automated Self-Administered 24hr Dietary Recall (ASA24).

    Measured: Pre (0), 24-hours Post (24H), 48-hours Post (48H)

  51. Diet - Daily Total Micronutrients

    Assessed via Automated Self-Administered 24hr Dietary Recall (ASA24). Participants report each eating occasion and the time of consumption during a 24-hour period.

    Measured: Pre (0), 24-hours Post (24H), 48-hours Post (48H)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06617351
Sponsor's protocol ID
STUDY00006674
Status last verified
Sep 2024
First submitted
24 Sep 2024
Last updated
1 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wells AJ, Hoffman JR, Jajtner AR, Varanoske AN, Church DD, Gonzalez AM, Townsend JR, Boone CH, Baker KM, Beyer KS, Mangine GT, Oliveira LP, Fukuda DH, Stout JR. The Effect of Post-Resistance Exercise Amino Acids on Plasma MCP-1 and CCR2 Expression. Nutrients. 2016 Jul 2;8(7):409. doi: 10.3390/nu8070409.

    PubMed 27384580

  • Aderem A, Underhill DM. Mechanisms of phagocytosis in macrophages. Annu Rev Immunol. 1999;17:593-623. doi: 10.1146/annurev.immunol.17.1.593.

    PubMed 10358769

  • Chazaud B, Brigitte M, Yacoub-Youssef H, Arnold L, Gherardi R, Sonnet C, Lafuste P, Chretien F. Dual and beneficial roles of macrophages during skeletal muscle regeneration. Exerc Sport Sci Rev. 2009 Jan;37(1):18-22. doi: 10.1097/JES.0b013e318190ebdb.

    PubMed 19098520

  • Arnold L, Henry A, Poron F, Baba-Amer Y, van Rooijen N, Plonquet A, Gherardi RK, Chazaud B. Inflammatory monocytes recruited after skeletal muscle injury switch into antiinflammatory macrophages to support myogenesis. J Exp Med. 2007 May 14;204(5):1057-69. doi: 10.1084/jem.20070075. Epub 2007 May 7.

    PubMed 17485518

  • Pozo D, Garcia-Maurino S, Guerrero JM, Calvo JR. mRNA expression of nuclear receptor RZR/RORalpha, melatonin membrane receptor MT, and hydroxindole-O-methyltransferase in different populations of human immune cells. J Pineal Res. 2004 Aug;37(1):48-54. doi: 10.1111/j.1600-079X.2004.00135.x.

    PubMed 15230868

  • Morrey KM, McLachlan JA, Serkin CD, Bakouche O. Activation of human monocytes by the pineal hormone melatonin. J Immunol. 1994 Sep 15;153(6):2671-80.

    PubMed 8077674

  • Calvo JR, Gonzalez-Yanes C, Maldonado MD. The role of melatonin in the cells of the innate immunity: a review. J Pineal Res. 2013 Sep;55(2):103-20. doi: 10.1111/jpi.12075. Epub 2013 Jul 24.

    PubMed 23889107

  • Maldonado MD, Manfredi M, Ribas-Serna J, Garcia-Moreno H, Calvo JR. Melatonin administrated immediately before an intense exercise reverses oxidative stress, improves immunological defenses and lipid metabolism in football players. Physiol Behav. 2012 Mar 20;105(5):1099-103. doi: 10.1016/j.physbeh.2011.12.015. Epub 2011 Dec 22.

    PubMed 22212240

  • Nassar E, Mulligan C, Taylor L, Kerksick C, Galbreath M, Greenwood M, Kreider R, Willoughby DS. Effects of a single dose of N-Acetyl-5-methoxytryptamine (Melatonin) and resistance exercise on the growth hormone/IGF-1 axis in young males and females. J Int Soc Sports Nutr. 2007 Oct 23;4:14. doi: 10.1186/1550-2783-4-14.

    PubMed 17956623

  • Ochoa JJ, Diaz-Castro J, Kajarabille N, Garcia C, Guisado IM, De Teresa C, Guisado R. Melatonin supplementation ameliorates oxidative stress and inflammatory signaling induced by strenuous exercise in adult human males. J Pineal Res. 2011 Nov;51(4):373-80. doi: 10.1111/j.1600-079X.2011.00899.x. Epub 2011 May 26.

    PubMed 21615492

Questions about this trial

What is this clinical trial studying?

A study testing Melatonin in people with Cell Migration and Cell Invasion, run by University of Central Florida 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 11 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adam J Wells, PhD (407-823-3906, adam.wells@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Sleep Duration (time frame: Pre (0), Immediately-post (IP), 4-hours Post (4H), 24-hours post (24H), 48-hours post (48H)). The study lists 51 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 NCT06617351, which also lists 10 linked publications.

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 1 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in