Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial

Inclusion criteria

• 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

Exclusion criteria

• 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