Health TrialsbyHealthPanel

Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress

ConditionsStressMental Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBaylor University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Melatonin 3 MG Oral Tablet

    Dietary supplement

    Participants will ingest an acute 3mg oral melatonin tablet

  • 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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Melatonin (3mg)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks
2

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.

Time frame
4 weeks
3

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.

Time frame
4 weeks

Secondary outcomes

1

Perceived Stress and Coping (Likert Scale)

Participants' stress and perceived coping will be monitored throughout the stress task in both experimental conditions. Participants will be asked to rate their perceived stress on a Likert scale ranging from 1 (not at all stressed) to 7 (extremely stressed). Participants will also be asked to rate how well they perceived their ability to cope with the demands of the tasks on a scale ranging from 1 (not at all able to cope) to 7 (extremely able to cope). The quotient of stress/coping will be operationalized as a measure of threat perception. A challenge appraisal is defined as a stress-coping ratio of ≤1 (i.e., coping ability meets or exceeds the perceived stress of the task) whereas a threat appraisal is defined as a stress-coping ratio \> 1 (i.e., perceived stress of the task exceeds coping abilities). Comparisons between conditions will be performed to assess the differences in numeric ratings of stress, coping, and threat perception measured in arbitrary units.

Time frame
4 weeks
2

Karolinska Sleepiness Scale

The Karolinska Sleepiness Scale will be used to assess participants' reported sleepiness prior to stress task initiation. The scale ranges from 1 (extremely alert) to 10 (Extremely sleepy, can't stay awake) to measure momentary levels of sleepiness.

Time frame
4 weeks
3

Salivary Melatonin

Saliva will be sampled 45 minutes after melatonin or placebo ingestion. This will be used to quantify salivary melatonin between conditions.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor University

Lead sponsor

Source ClinicalTrials.gov
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