The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation
- Conditions
- Healthy
- Interventions
- Other: PlaceboDietary Supplement: melatonin
- Registration Number
- NCT04831398
- Lead Sponsor
- University of Oklahoma
- Brief 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.
- Detailed 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 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 be familiarized with experimental protocols. 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 (PLA/MEL) will begin with the subject lying supine for 5 min of quiet rest where baseline measurements are taken, followed by activation of the lower body negative pressure (LBNP) device causing suction at -20 mmHg. Following LBNP participants will be given 10 minutes of rest to recover all variables to pre-LBNP 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 LBNP device will be activated again to -20mmHg such that the participant will be completing LBNP 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Healthy men and women
- Women must be premenopausal with a regular menstrual cycle (26-30 days)
- History of autonomic dysfunction
- Cardiovascular diseases
- Diabetes
- Tobacco/nicotine use
- Systolic Pressure >= 130 mmHg
- Diastolic Pressure >= 85 mmHg
- Regular melatonin use >= 1 use/week
- Allergy to melatonin
- Cardiometabolic medication use (e.g. anti-hypertensives, insulin-sensitizing, statins)
- Sex hormone replacement medical use (e.g. testosterone, estrogen, progesterone)
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (PLA) is 10 sublingual sprays of a diluted (1 microliter/29ml filtered water) mint extract. Melatonin melatonin 5mg commercially available melatonin (MEL) spray will be given sublingually.
- Primary Outcome Measures
Name Time Method Mean Arterial Pressure 7 minutes of rest and 7 minutes of exercise average pressure within the arteries
Muscle Tissue Oxygenation 7 minutes of rest and 7 minutes of exercise Concentrations of Total, Oxy, and deoxyhemoglobin of Flexor Digitorum Profundus muscle of the forearm
- Secondary Outcome Measures
Name Time Method Cardiac Output 7 minutes of rest and 7 minutes of exercise volume of blood pumped by the heart per minute
Cerebral Oxygenation 7 minutes of rest and 7 minutes of exercise Concentrations of Total, Oxy, and deoxyhemoglobin of the Prefrontal Cortex of the brain
Heart Rate 7 minutes of rest and 7 minutes of exercise number of heart beats per minute
Respiratory Rate 7 minutes of rest and 7 minutes of exercise number of breaths per minute
Stroke Volume 7 minutes of rest and 7 minutes of exercise volume of blood pumped by the heart per heart beat
Total peripheral resistance 7 minutes of rest and 7 minutes of exercise amount of force affecting resistance to blood flow throughout the circulatory system
Heart Rate Variability 7 minutes of rest and 7 minutes of exercise measure of the variation in time between each heart beat
Trial Locations
- Locations (1)
Department of Health and Exercise Science
🇺🇸Norman, Oklahoma, United States