Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1
Completed NCT04052711 - A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design Phase 1
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT04319926 - Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects Phase 1
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Completed NCT03662100 - A Study of Two Formulations of LY3074828 in Healthy Participants Phase 1
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT03656952 - A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers Phase 1
Completed NCT03670082 - Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Phase 1
Completed NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Completed NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A