StressNCT07138443
Influence of Melatonin on Cardiovascular and Thermoregulatory Responses to Stress
A study testing Melatonin 3 MG Oral Tablet in people with Stress and Mental Stress, run by Baylor University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Mental Stress
- What is being tested?
- Melatonin 3 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Habitual smoking (6 or more cigarettes per week)
- Habitual alcohol consumption (more than 2 alcoholic drinks per day)
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Autonomic Function Laboratory
Waco, Texas, 76706
About this study
Official title: Influence of Melatonin on Cardiovascular and Skin Temperature Responses to Stress: A Randomized Controlled 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.
Read the detailed 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.
- Conditions
- Stress, Mental Stress
- Being tested
- Melatonin 3 MG Oral Tablet, Placebo Oral Tablet
- Keywords
- Melatonin, Mental stress, Trier Social Stress Test, Cardiovascular, Skin temperature
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 MG Oral TabletDietary supplement
Participants will ingest an acute 3mg oral melatonin tablet
Placebo Oral TabletDietary supplement
Participants will ingest a placebo tablet (sugar pill) of the same size, shape, and color of the active melatonin supplement
| Study group | Role | What they receive |
|---|---|---|
| Melatonin (3mg) | Experimental | Participants will ingest an acute oral melatonin tablet (3mg) prior to stress reactivity assessment. Receives: 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. Receives: Dietary Supplement: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Salivary Melatonin
Saliva will be sampled 45 minutes after melatonin or placebo ingestion. This will be used to quantify salivary melatonin between conditions.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Aug 2025
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138443
- Sponsor's protocol ID
- 2241833-5
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Melatonin on Cardiovascular and Skin Temperature Responses to Stress: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07138443
- Acronym / sponsor ID
- 2241833-5
- Conditions
- Stress, Mental Stress
- Keywords
- Melatonin, Mental stress, Trier Social Stress Test, Cardiovascular, Skin temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin (3mg) | Experimental | Dietary Supplement: Melatonin 3 MG Oral TabletParticipants will ingest an acute oral melatonin tablet (3mg) prior to stress reactivity assessment. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Oral TabletParticipants will ingest a placebo pill of the same color and shape as the melatonin tablet prior to reactivity assessment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 MG Oral TabletParticipants will ingest an acute 3mg oral melatonin tablet | Dietary supplement | Melatonin (3mg) |
| Placebo Oral TabletParticipants will ingest a placebo tablet (sugar pill) of the same size, shape, and color of the active melatonin supplement | Dietary supplement | Placebo |
Primary outcome
Heart Rate Reactivity
Time frame: 4 weeks
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.
Blood Pressure Reactivity
Time frame: 4 weeks
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.
Distal-to-Proximal Skin Temperature Gradient
Time frame: 4 weeks
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.
3 secondary outcomes
Perceived Stress and Coping (Likert Scale)
Time frame: 4 weeks
Karolinska Sleepiness Scale
Time frame: 4 weeks
Salivary Melatonin
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 3 MG Oral Tablet in people with Stress and Mental Stress, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Reactivity (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.