Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Nocturnal Systolic Blood Pressure (SBP)
研究概览
简要总结
The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 40-55 years old
- •Female individuals with intact uterus and at least one ovary
- •Hypertension
- •o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
- •On stable medical regimen (≥ 2 months) if taking other medications
排除标准
- •Prescription sleeping medications or melatonin supplementation
- •Pregnant or lactating
- •Use of tobacco, nicotine or vaping products
- •Night shift work
- •On prescription aspirin
- •Severe lactose intolerance
- •History of substance use disorder
- •History of suicidal ideation
- •History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (<11.6 g/dL) within the past 12 months
- •Active cancer
- •Severe daytime sleepiness (score >15 at the Epworth Sleepiness Scale [ESS])81
- •Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators
- •Inability to provide written consent and/or to speak and read English
- •Any other medical, geographic, or social factor making study participation impractical
研究组 & 干预措施
Placebo
placebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler.
干预措施: Placebo (Dietary Supplement)
Melatonin
Melatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women.
干预措施: Terry Naturally® melatonin 5mg SR (Dietary Supplement)
结局指标
主要结局
Change in Nocturnal Systolic Blood Pressure (SBP)
时间窗: Measured at baseline and at the end of the 12-week intervention
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
Change in Nocturnal Diastolic Blood Pressure (DBP)
时间窗: Measured at baseline and at the end of the 12-week intervention.
Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
次要结局
- Change in Oxidative Stress Markers(Measured at baseline and at the end of the 12-week intervention.)
研究者
Naima Covassin
Principal Investigator
Mayo Clinic