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

Part of paid clinical trials in Orlando, Florida.

Sponsor
University of Central Florida
Study ID
NCT06617351
Status
Not Yet Recruiting

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Conditions

  • Cell Invasion
  • Cell Migration
  • Exercise Recovery

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Melatonin — DIETARY_SUPPLEMENT
    Gummy - 7.5 kilocalories (kCal), 2 g Carbohydrate, 1.5 g total sugars, 7.5 mg sodium, 5 mg melatonin.
  • Placebo — DIETARY_SUPPLEMENT
    Gummy - 12.5 kilocalories (kCal), 3g Carbohydrate, 1.875 g total sugars, 1.25 mg sodium.

Study Details

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 Dates

Start date
Oct 1, 2024
Status verified
Sep 2024
Primary completion
Mar 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Melatonin
    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.
  • Placebo Comparator: Placebo
    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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kinesiology Research LabsOrlandoFlorida32816-

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Kinesiology Research Labs· Orlando, FL

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