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