Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

NCT07138443 | Recruiting

• 1 other identifier: 2241833-5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress; Mental Stress

Keywords

Melatonin; Mental stress; Trier Social Stress Test; Cardiovascular; Skin temperature

Outcome Measures

Primary Outcomes (3)

• Heart Rate Reactivity

  Heart rate will be continuously monitored using electrocardiogram during a 10-minute baseline and in response to the Trier Social Stress Test. Heart rate reactivity during the stress will be quantified.

  4 weeks

• Blood Pressure Reactivity

  Beat-by-beat systolic, diastolic, and mean arterial pressure will be assessed using finger plethysmography in response to the Trier Social Stress Test. Reactivity scores will be assessed by determining the difference in blood pressure during the stress task relative to baseline.

  4 weeks

• Distal-to-Proximal Skin Temperature Gradient

  Skin temperature will be monitored using small temperature sensors (iButtons, type DS1922L; iButtonLink LLC) adhered to various distal and proximal regions of the body. Upper distal to proximal skin temperature gradients (DPG) will be calculated as the average skin temperature taken from the hand subtracted from the average skin temperature taken from the forearm/shoulder. Lower DPG will be calculated as the average skin temperature taken from the feet subtracted from the average skin temperature recorded at the calves.

  4 weeks

Secondary Outcomes (3)

• Perceived Stress and Coping (Likert Scale)

  4 weeks

• Karolinska Sleepiness Scale

  4 weeks

• Salivary Melatonin

  4 weeks

Study Arms (2)

Melatonin (3mg)

EXPERIMENTAL

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

Dietary Supplement: Melatonin 3 MG Oral Tablet

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Oral Tablet

Interventions

Melatonin 3 MG Oral Tablet DIETARY_SUPPLEMENT

Participants will ingest an acute 3mg oral melatonin tablet

Melatonin (3mg)

Placebo Oral Tablet DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

Baylor University Autonomic Function Laboratory

Waco, Texas, 76706, United States

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Interventions

Melatonin; Tablets

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Jeremy A Bigalke, PhD

CONTACT

2547104399; jeremy_bigalke@baylor.edu

Anna Murvich

CONTACT

254-710-4475; anna_muvich@baylor.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)