Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin (3mg) | Experimental | Participants will ingest an acute oral melatonin tablet (3mg) prior to stress reactivity assessment. |
|
| Placebo | Placebo Comparator | Participants will ingest a placebo pill of the same color and shape as the melatonin tablet prior to reactivity assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 3 MG Oral Tablet | Dietary Supplement | Participants will ingest an acute 3mg oral melatonin tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy A Bigalke, PhD | Contact | 2547104399 | jeremy_bigalke@baylor.edu | |
| Anna Murvich | Contact | 254-710-4475 | anna_muvich@baylor.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Autonomic Function Laboratory | Recruiting | Waco | Texas | 76706 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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 |
|
| 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. | 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. | 4 weeks |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |