Melatonin for Exercise Recovery

Overseen By Kadie Drahos, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Must not be taking: Melatonin, Performance-enhancing drugs

Disqualifiers: Pregnancy, Amenorrhea, Others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether melatonin can aid muscle recovery after intense exercise by influencing the body's immune and inflammation responses. Researchers aim to determine if melatonin improves muscle sensation and performance following a strenuous workout. Participants will receive either melatonin or a placebo (a non-active substance resembling the treatment) to compare results. Individuals who have engaged in regular resistance training (such as weightlifting) for at least six months and are prepared for physical activity may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how melatonin might support muscle recovery.

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.

Is there any evidence suggesting that melatonin is likely to be safe for humans?

Research has shown that melatonin is usually safe as a supplement. Studies suggest it can aid muscle recovery after exercise and generally does not cause serious side effects. However, long-term use might increase the risk of heart failure in some adults. This trial involves taking melatonin for just three days, a short period, so the risk from long-term use might not apply. Always consult a healthcare provider before starting any new supplement, especially if there are health concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Melatonin is unique for exercise recovery because it leverages its natural, sleep-regulating properties to potentially enhance muscle repair and reduce inflammation after intense workouts. Unlike typical recovery aids like protein supplements and anti-inflammatory drugs, melatonin offers a novel approach by possibly improving sleep quality, which is crucial for recovery. Researchers are excited about melatonin because it could provide a simple, cost-effective way to speed up recovery times without the side effects associated with many traditional medications. Plus, its natural origin makes it an appealing option for those looking for holistic recovery methods.

What evidence suggests that melatonin might be an effective treatment for exercise recovery?

This trial will evaluate the effects of melatonin on exercise recovery. Research has shown that melatonin might aid the body in recovering after exercise. One study found that taking 10 mg of melatonin after evening exercise improved sleep and activity levels the next day. Another study found that taking 6 mg of melatonin at night boosted performance in high-intensity exercise the next day and improved well-being up to 72 hours after working out. Melatonin may also increase energy before exercise and speed up muscle recovery. These findings suggest that melatonin could be useful for recovering from tough workouts. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I do not agree to participate in the study.

I am currently taking melatonin.

Not meeting requirements for resistance trained status

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Melatonin

Trial Overview The 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.

How Is the Trial Designed?

Group I: Melatonin Experimental Treatment 1 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: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of circadian rhythm disorders--melatonin. Arendt, J., Deacon, S.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7072499/

Impact of Melatonin on Skeletal Muscle and Exercise - PMC Moreover, 10 mg melatonin taken after strenuous exercise in late evening was effective to prolong sleep and to ameliorate short–term activity in the following ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40559702/

Melatonin Supplementation Enhances Next-Day High ... In summary, 6 mg of melatonin taken at night enhanced next-day high-intensity exercise performance and improved perceived recovery up to 72 ...

3. mdpi.com mdpi.com/2075-4663/13/6/190

Melatonin Supplementation Enhances Next-Day High- ... 6 mg of melatonin taken at night enhanced next-day high-intensity exercise performance and improved perceived recovery up to 72 h post-exercise.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1440244021001328

How does sleep help recovery from exercise-induced ... Accumulating evidence demonstrates that sleep extension improved performance, pain sensitivity and GH/IGF-I anabolic responses, which may be beneficial in ...

5. nature.com nature.com/articles/s41598-021-97364-7

Acute melatonin administration improves exercise ... Melatonin increased energy substrate availability prior to exercise, improved the exercise tolerance, and accelerated the recovery of muscle energy substrates ...

6. foxnews.com foxnews.com/health/new-health-warning-issued-over-popular-sleep-aid-millions-take-nightly

New health warning issued over popular sleep aid millions ... A new American Heart Association study finds that long-term melatonin use is linked to 90% increased risk of heart failure in adults with ...

7. troscriptions.com troscriptions.com/blogs/main/melatonin-and-endurance?srsltid=AfmBOor7I6LXncay3uKFrW1JFjOd9ndVOJTw0ANxFtccUOCuGuu3S0N6

The Role of Melatonin in Endurance, Recovery, and Athletic ... Long-term safety data remain limited, but no serious adverse events have been consistently linked to melatonin. Athletes should ensure melatonin supplements ...

8. ema.europa.eu ema.europa.eu/en/documents/assessment-report/slenyto-epar-public-assessment-report_en.pdf

Assessment report - Slenyto - European Medicines Agency There is a need for more long-term safety data on the safety of melatonin in general and more specifically related to pubertal development. However, this ...