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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Cell Migration, Cell Invasion, Exercise Recovery

In brief

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.

Key facts

Study ID: NCT06617351
Run by: University of Central Florida
People needed: 24
Starts: 2024-10-01
Expected to finish: 2025-07-31
Last updated by the study team: 2024-10-01

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.
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).

You may not qualify if…

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.
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.

Where it is running

Kinesiology Research Labs — Orlando, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.