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Hormone Therapy

Melatonin for Exercise Recovery

N/A

Waitlist Available

Research Sponsored by University of Central Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female between the ages of 18-40 years old

Premenopausal with an identifiable onset of menses

Must not have

Individual does not agree to participate in the study

Currently taking melatonin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up -24 hours before (-24h), 24-hours post (24h), 48-hours post (48h)

Summary

"This trial aims to study the effects of taking a 5mg oral melatonin supplement three times a day before and after intense exercise. The goal is to see how melatonin affects the body's immune

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Melatonin may cause drowsiness, headache, dizziness or nausea. Since it's often used as a sleep aid, it could potentially affect your wake-sleep pattern especially when taken multiple times throughout the day.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

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I am premenopausal and have regular menstrual cycles.

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I have no lower body injuries that limit my ability to exercise.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not agree to participate in the study.

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I am currently taking melatonin.

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I am not currently having regular menstrual periods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ -24 hours before (-24h), 24-hours post (24h), 48-hours post (48h)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~-24 hours before (-24h), 24-hours post (24h), 48-hours post (48h)

This trial's timeline: 3 weeks for screening, Varies for treatment, and -24 hours before (-24h), 24-hours post (24h), 48-hours post (48h) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Active Range of Motion (AROM)

Diet - Daily Carbohydrate

Diet - Daily Fat

+48 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

0 / 6Eligibility criteria met