Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

Baylor University

Status: Enrolling

Conditions: Mental Stress; Stress

Treatments: Dietary Supplement: Melatonin 3 MG Oral Tablet; Dietary Supplement: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07138443

2241833-5

Details and patient eligibility

About

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.

Full description

This study will utilize a randomized, crossover, placebo controlled experimental approach to determine the effects of acute oral melatonin supplementation (3mg) on blood pressure, heart rate, and regionalized skin temperature responsiveness to mental stress. The study will assess beat-by-beat blood pressure (finger plethysmography), continuous heart rate (electrocardiogram), and proximal/distal skin temperature continuously at rest and in response to the Trier Social Stress Test following either afternoon melatonin or placebo ingestion in a randomized order. Participants will consist of young healthy adults.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Melatonin (3mg)

Experimental group

Description:

Participants will ingest an acute oral melatonin tablet (3mg) prior to stress reactivity assessment.

Treatment:

Dietary Supplement: Melatonin 3 MG Oral Tablet

Placebo

Placebo Comparator group

Description:

Participants will ingest a placebo pill of the same color and shape as the melatonin tablet prior to reactivity assessment.

Treatment:

Dietary Supplement: Placebo Oral Tablet