Melatonin effects on heart rate, blood pressure, and skin temperature during mental stress
Influence of Melatonin on Cardiovascular and Skin Temperature Responses to Stress: A Randomized Controlled Trial
This study will test whether taking a single 3 mg melatonin pill in the afternoon reduces blood pressure, heart rate, and skin temperature reactions to a short mental stress task in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Baylor University Academic / other |
| Locations | 1 site (Waco, Texas) |
| Trial ID | NCT07138443 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled, crossover experiment in which healthy young adults receive a single 3 mg oral dose of melatonin or a matching placebo on separate visits. Testing occurs in the afternoon with continuous beat-by-beat blood pressure (finger plethysmography), ECG heart rate monitoring, and proximal/distal skin temperature recordings at rest and during the Trier Social Stress Test. Each participant serves as their own control by undergoing both melatonin and placebo sessions in randomized order. The design isolates acute effects of melatonin on cardiovascular and thermoregulatory responses to a standardized mental stressor.
Who should consider this trial
Good fit: Healthy adults aged 18–70 with BMI <30 who can abstain from caffeine, exercise, and alcohol before visits, with menstruating women scheduled in an early follicular or low-hormone phase or postmenopausal women eligible.
Not a fit: People with major psychiatric disorders, unstable or serious medical conditions (including significant cardiovascular disease or diabetes), diagnosed circadian rhythm sleep disorders, high obstructive sleep apnea risk, or BMI ≥30 are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, this could offer a simple, low-cost way to reduce short-term physiological stress responses and lower acute cardiovascular strain during mental stress.
How similar studies have performed: Previous work shows melatonin can lower nocturnal blood pressure and alter body temperature, but using a single 3 mg dose to blunt acute cardiovascular responses to mental stress is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Waco, Texas
- Baylor University Autonomic Function Laboratory — Waco, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jeremy A Bigalke, PhD
- Email: jeremy_bigalke@baylor.edu
- Phone: 2547104399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.