RecruitingNot ApplicableNCT07138443

Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

Influence of Melatonin on Cardiovascular and Skin Temperature Responses to Stress: A Randomized Controlled Trial


Sponsor

Baylor University

Enrollment

20 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria9

  • 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.)
  • Current, or use within past month, of psychoactive (other than stable treatment with antidepressant), hypnotic, stimulant or analgesic medication (except occasional non-narcotic analgesics), beta blockers, or alpha blockers
  • Shift work or other types of self-imposed irregular sleep schedules
  • Habitual smoking (6 or more cigarettes per week)
  • Habitual alcohol consumption (more than 2 alcoholic drinks per day)
  • Pregnancy or breast feeding

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Interventions

DIETARY_SUPPLEMENTMelatonin 3 MG Oral Tablet

Participants will ingest an acute 3mg oral melatonin tablet

DIETARY_SUPPLEMENTPlacebo Oral Tablet

Participants will ingest a placebo tablet (sugar pill) of the same size, shape, and color of the active melatonin supplement


Locations(1)

Baylor University Autonomic Function Laboratory

Waco, Texas, United States

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NCT07138443


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