Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stress Mental Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Both the investigator and the participants will be blinded as to the condition that participants are in. A lab member who will be recused from data analysis and outcomes assessment will monitor participant assignment to study condition.

Study Groups

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Melatonin (3mg)

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

Group Type EXPERIMENTAL

Melatonin 3 MG Oral Tablet

Intervention Type DIETARY_SUPPLEMENT

Participants will ingest an acute 3mg oral melatonin tablet

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Melatonin 3 MG Oral Tablet

Participants will ingest an acute 3mg oral melatonin tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo Oral Tablet

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes