Influence of Melatonin on Cardiovascular and Skin Temperature Responses to Stress: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Heart Rate Reactivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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.
排除标准
- •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
研究组 & 干预措施
Melatonin (3mg)
Participants will ingest an acute oral melatonin tablet (3mg) prior to stress reactivity assessment.
干预措施: Melatonin 3 MG Oral Tablet (Dietary Supplement)
Placebo
Participants will ingest a placebo pill of the same color and shape as the melatonin tablet prior to reactivity assessment.
干预措施: Placebo Oral Tablet (Dietary Supplement)
结局指标
主要结局
Heart Rate Reactivity
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Perceived Stress and Coping (Likert Scale)(4 weeks)
- Karolinska Sleepiness Scale(4 weeks)
- Salivary Melatonin(4 weeks)