Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBaylor University
About this trial
This study aims to evaluate the influence of acute oral melatonin supplementation on cardiovascular and skin temperature responses to mental stress. The hypothesis is that acute melatonin will lead to reduced cardiovascular and skin temperature responsiveness to acute mental stress.
Eligibility criteria
Qualifiers
Must be between the ages of 18-70 years old.
All subjects will be required to abstain from exercise and caffeine for 12 h, and alcohol for 24 h prior to the experiment.
BMI must be <30 kg/m2.
Menstruating women will initially be tested during their early follicular phase (2-5 days after initiating menstruation) or during low hormone phase (2-5 days after initiating menstruation) if on oral contraceptives to control for potential impact of sex steroids. Post-menopausal females (>5 years) will also be included. Females must have an intact uterus and at least one ovary. Use of hormonal replacement therapy will be allowed.
Disqualifiers
Circadian rhythm sleep disorders
High obstructive sleep apnea diagnosis determined by STOP-BANG.
History of meeting Diagnostic and Statistical Manual of Mental health (DSM-V) criteria of major psychiatric disorder
Unstable or serious medical conditions (heart failure, diabetes, cardiovascular disease, etc.)
Trial design
Treatments tested in this trial
- Melatonin 3 MG Oral Tablet
- Placebo Oral Tablet
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov