24 Participants Needed

Melatonin for Exercise Recovery

AJ
KD
Overseen ByKadie Drahos, BS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Central Florida
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You cannot participate if you are regularly taking any prescription or over-the-counter medication that might affect the study assessments. If you are taking certain dietary supplements, you may need to stop them for a 4-week period before joining the study.

What evidence supports the effectiveness of the drug melatonin for exercise recovery?

Research shows that melatonin can help improve sleep efficiency and adjust the body's internal clock, which may aid athletes in recovering from exercise. Additionally, melatonin has been found to reduce muscle damage and inflammation after intense exercise, suggesting it could be beneficial for exercise recovery.12345

Is melatonin safe for human use?

Melatonin is generally considered safe for short-term use in humans, with studies showing low toxicity and beneficial effects on sleep and circadian rhythms. However, there is limited long-term safety data, and its effects during pregnancy or interactions with other medications are not well-studied.14678

How does the drug melatonin differ from other treatments for exercise recovery?

Melatonin is unique for exercise recovery because it helps synchronize the body's internal clock, improving sleep quality and efficiency, which can enhance recovery. Unlike other treatments, melatonin also increases energy availability in muscles and improves exercise tolerance, making it beneficial for athletes.12467

Eligibility Criteria

This trial is for resistance-trained men and women interested in how melatonin might help with muscle recovery after intense exercise. Participants should be healthy, regularly engage in resistance training, and not currently use any supplements that contain melatonin.

Inclusion Criteria

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 with defined sessions per week and at least one lower body session
Not currently pregnant and no intention to become pregnant during participation
See 8 more

Exclusion Criteria

I do not agree to participate in the study.
I am currently taking melatonin.
Not meeting requirements for resistance trained status
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Pre-treatment

Participants begin melatonin or placebo supplementation 24 hours before the exercise bout

1 day
1 visit (in-person)

Treatment

Participants undergo an acute bout of dynamic high-intensity resistance exercise and continue supplementation for 48 hours post-exercise

3 days
Multiple assessments at Pre, Immediately-post, 4-hours Post, 24-hours post, and 48-hours post-exercise

Follow-up

Participants are monitored for systemic and cellular responses, and functional recovery measures are assessed

1 week

Treatment Details

Interventions

  • Melatonin
Trial OverviewThe study tests if taking a melatonin supplement (5mg, three times daily) helps with cellular responses and physical recovery following a session of strenuous weightlifting. Half the participants will receive melatonin; the other half will get a placebo without knowing which one they're taking.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MelatoninExperimental Treatment1 Intervention
Participants 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.
Group II: PlaceboPlacebo Group1 Intervention
Participants 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.

Melatonin is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Circadin for:
  • Insomnia in adults aged 55 and over
  • Sleep disorders in children with autism spectrum disorder
🇪🇺
Approved in European Union as Slenyto for:
  • Insomnia in children and adolescents aged 2-18 with autism spectrum disorder
🇺🇸
Approved in United States as Melatonin for:
  • Sleep disorders in children with autism spectrum disorder
  • Insomnia in adults

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials
101
Recruited
1,191,000+

Findings from Research

Melatonin can effectively improve sleep and adjust circadian rhythms when taken at the right times, helping with issues like jet lag and shift work, but its effectiveness is closely related to the timing and dosage.
While melatonin is generally safe for short-term use in healthy adults, there is a lack of long-term safety data, and its use should be carefully managed to avoid potential negative effects, especially with unregulated preparations.
Treatment of circadian rhythm disorders--melatonin.Arendt, J., Deacon, S.[2019]

References

The benefits of four weeks of melatonin treatment on circadian patterns in resistance-trained athletes. [2015]
The relevance of melatonin to sports medicine and science. [2018]
Melatonin Has An Ergogenic Effect But Does Not Prevent Inflammation and Damage In Exhaustive Exercise. [2018]
Acute and delayed effects of exercise on human melatonin secretion. [2017]
Melatonin ingestion after exhaustive late-evening exercise attenuate muscle damage, oxidative stress, and inflammation during intense short term effort in the following day in teenage athletes. [2021]
Melatonin ingestion after exhaustive late-evening exercise improves sleep quality and quantity, and short-term performances in teenage athletes. [2019]
Acute melatonin administration improves exercise tolerance and the metabolic recovery after exhaustive effort. [2023]
Treatment of circadian rhythm disorders--melatonin. [2019]