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Clinical Trial Summary

the purpose of this experiment is to determine if acute melatonin supplementation alters central and peripheral cardiovascular responses to a cold pressor test at rest and during dynamic exercise.


Clinical Trial Description

After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the University of Oklahoma Norman campus. All subjects will complete a total of 3 visits. The first is a screening and time control visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once consented and enrolled, participants will complete a time control trial (CON). On separate days (visits 2 and 3), participants will complete placebo (PLA) and melatonin (MEL) in a randomly ordered, single-blind, counter-balanced design. PLA or MEL treatment will precede testing by 30min to maximize absorption into the circulation (Bartoli, 2013). All experiments (CON/PLA/MEL) will begin with the subject lying supine for 5 min of quiet rest where baseline measurements are taken, followed by their left foot being passively placed in the iced water to complete a cold pressor test (CPT). Following the CPT participants will be given 10 minutes of rest to recover all variables to pre-CPT values. After which participants will be given a hand grip dynamometer to complete 7 minutes of exercise at an intensity of 20% MVC at a 1s contraction to 2s relaxation cycle paced by a metronome. During the final 2 minutes of the 7 minutes of exercise the participant's right foot will be placed in the iced water such that the participant will be completing a CPT during rhythmic grip exercise. After the completion of exercise, the subject will remain supine for 10min. Then the a Total Labile Signal (TLS) procedure will be conducted. Where the experimental limb is occluded using a blood pressure cuff for 5min. The cuff is then rapidly deflated. The lowest oxyhemoglobin measured during the occlusion is recorded. After the TLS procedure, the subject will be de-instrumented and will leave the laboratory. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04831398
Study type Interventional
Source University of Oklahoma
Contact Jeremy M Kellawan, PhD
Phone 405 325 9028
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date May 1, 2021
Completion date May 1, 2023

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